Careers

The Account Manager is responsible for multiple Poly-Med accounts, outlined on customer and project trackers. This position works with other members of the business development team and company as a whole to develop new opportunities through existing clients and developing new clients. Specifically, this employee is responsible for growing revenue related to their specific clients and helping those clients bring their products to market.

Responsibilities:

• Generate revenue by discussing, preparing and executing proposals with customers.
• Develop current accounts through efficient follow through as well as exploration of other synergistic activities between companies.
• Interact with Sales to develop new clients and identify key decision makers to communicate with.
• Interface with Product Managers to continually develop product lines based on experience with clients.
• Develop and maintain consistent communication and delivery with accounts.
• Ensure customer satisfaction and success while managing Poly-Med interests such as intellectual property project profitability etc.
• Will participate in lab work as needed
• Assist with and ensure continuity in contractual agreements with accounts

Required/Preferable Knowledge, Skills and Abilities

• Organized
• Team Player
• Confident
• Can easily communicate with individuals with various levels of technical experience
• Effective presentation skills
• Ability to facilitate small groups
• Logical and critical thinking
• Expert problem-solver
• Ability to influence and persuade
• Ability to handle multiple and competing priorities
• Ability to balance big-picture view with details and issues

Education/Experience Requirements:

Minimum of BS degree in Chemistry, Chemical Engineering, Polymer and Fiber Chemistry, Materials Science and Engineering or related discipline. Master’s preferred.

Working Conditions at Poly-Med, Inc.:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Entry to mid-level scientist position responsible for supporting a wide variety of laboratory testing related activities and tasks. This person will be relied upon to frequently exercise judgement based on gained knowledge, skills and experience. This role is an Independent Contributor role with no direct reports; however, this role may review the work of technicians. Interaction is with engineering and laboratory personnel. This position reports to the Analytics Laboratory Supervisor, or Lab Services Lead or Manager.

Responsibilities:

• Perform all lab functions under cGMP and ISO 13485 guidelines and PMI Quality Policy.
• Able to help develop new test methods and perform validations.
• Able to perform all technical functions including Quality Control release type testing, customer. analyses, and other requested tests.
• Troubleshoots and provides resolution to testing and lab issues.
• Able to perform unbiased, in-process and finished goods testing according to standardized procedures as required to support product realization.
• Provides data review of lab results as requested.
• Responsible for PM, calibration, and proper maintenance of some or all analytical equipment in lab.
• Train and provide mentorship to Technicians.
• Write testing reports, TMs, and/or SOPs as assigned by the supervisor or manager.
• Able to install and qualify analytical equipment.
• Helps with or responsible for lab planning, organization, 5S, validation activities.

Required/Preferable Knowledge, Skills and Abilities

• Required experience with basic analytical laboratory equipment and techniques – preferred experience in microscopy, physical testing such as (but not limited to) hardness and bending.
• Experience in medical grade silicone is desirable.
• Experience with basic computer skills, such as Microsoft Office (Excel, Word, Outlook), is required.
• Strong math skills and ability to perform calculations as needed is required.
• Dependable, detail oriented, organized and efficient, precise
• Ability to follow written and verbal instructions with repeatable and accurate results
• Excellent written and verbal communication and data recording ability
• Ability to deal effectively with time pressures, stress, and changing demands of job on a regular basis

Education/Experience Requirements:

Required: At a minimum Bachelor’s Degree in Chemistry or related science and at least 3-5 years laboratory experience

Preferred: Master’s Degree in Chemistry and at least 3-5 years laboratory experience

Working Conditions at Poly-Med, Inc.:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals. Employees must be able to adapt to indoor work environment. The following physical requirements can include: sitting, standing, walking, climbing/balancing, reaching, stooping/kneeling/crouching/crawling, talking, hearing, feeling/touching, vision (close, peripheral, depth, ability to adjust focus).

Poly-Med, Inc. offers a great selection of benefits including vacation time.

Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Description:

The IT Support Specialist will assist the IT Systems Administrator with install, monitor, repair, maintain, and upgrading Poly-Med, Inc.’s network and computer system.

Responsibilities:

• Responsible for installing network and computer systems.
• Responsible for maintaining, repairing, and upgrading network and computer systems.
• Diagnosing and troubleshooting potential network problems.
• Monitors network and systems to improve performance.
• Creates, maintains, and organizes backups (onsite and offsite).
• Ensures security and integrity of all company data.
• Ensures all devices are properly updated.
• Assists in the planning and preparation for future projects/upgrades.
• Performs logging of backups.
• Participates in continuous education of technological changes and advancements.
• Responsible for the assignment and tracking of all company devices (computers, routers, switches, phones, printers, scanners).
• Building Access system tasks
• Phone Systems tasks
• Oversee maintenance, upgrades, and backups to analytical workstations.
• Responding to Help Desk Tickets

Required/Preferable Knowledge, Skills and Abilities

Microsoft Domain Environment

• Active Directory
• Group Policy
• RDS/Terminal Services
• Office 365 Exchange Online
• Office 16 Suite
• Powershell
• VBA
• IIS
• SQL/MySQL/Oracle
• Windows XP, 7, and 10
• Server 2008, Server 2012 Std/R2, Server 2016

VMware 6.5

• Host and SAN environment
• Veeam Backup Solutions

Networking Devices

• General Knowledge of Routing and Switching/Networking Protocols
• TCP/IP
• Subnets
• Cable making skills
• Dell/Netgear PoE Switches
• Ubiquiti Systems
• VPN
• Fortinet

VoIP

• AVAYA System

PC Hardware Maintenance Knowledge

Network Security

• Firewall
• Security Policies

Excellent Soft Skills

Java and VB experience/skills a plus

SharePoint Database administration experience a plus.

Education/Experience Requirements:

Required: Associates Degree in Network Administration

Preferred: 2 – 5-years’ experience in Network Administration and/or Help Desk, Current A+; Current Network +

Environmental Requirements:

Must be able to adapt to multiple indoor work environments (shared office space, shared lab space and production areas).

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Position Summary:

Poly-Med, Inc. is seeking candidates that have experience with working in a fast paced environment, motivated, enthusiastic, and works well in both a team and individual setting. Our polymer manufacturing technicians play a critical role in the manufacturing process of creating our products. Candidates with experience in restaurants as either a waiter or waitress will make the ideal candidate.

Responsibilities:

• Maintaining the manufacturing area including cleaning of glassware, waste management, transfer of materials to and from inventory, keeping track of raw material consumption, and general housekeeping including maintenance of equipment.
• Batch manufacturing to include weighing and charging raw materials to vessels, transferring products from vessels to storage containers, and product processing.
• Read, record and interpret data from instruments, reactors, pumps, etc. to adjust as required to affect efficient and safe operations.
• Understand the key process variables which impact product and quality/consistency
• Follows company policies, principles, procedures, standards, and practices to ensure safe and reliable operation.
• Contributes towards the positive and energetic culture
• Fully support Poly-Med’s goals of zero workplace safety incidents and participates in EHS programs
• Performs related duties as assigned.

Required/Preferable Knowledge, Skills and Abilities

• Positive Attitude
• Attention to details
• Time Management
• Ability to listen and communicate effectively.
• Experience in the food service industry is helpful.
• Willingness to learn, listen to directions and accept guidance.

Education/Experience Requirements:

Required: High School Diploma or GED

Environmental Requirements:

Must be able to adapt to multiple indoor work environments (shared office space, shared lab space and production areas).

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Position Summary:

Poly-Med, Inc. is seeking candidates that have experience with working in a fast paced environment, motivated, enthusiastic, and works well in both a team and individual setting. Our polymer manufacturing technicians play a critical role in the manufacturing process of creating our products. Candidates with experience in restaurants as either a waiter or waitress will make the ideal candidate.

Responsibilities:

• Maintaining the manufacturing area including cleaning of electrospinning components, waste management, transfer of materials to and from inventory, keeping track of raw material consumption, and general housekeeping including maintenance of equipment.
• Completing tasks including setting machines for production runs, post processing, and preparing cleanroom.
• Read, record and interpret data from instruments, etc. to adjust as required to affect efficient and safe operations.
• Understand the key process variables which impact product and quality/consistency
• Follows company policies, principles, procedures, standards, and practices to ensure safe and reliable operation.
• Contributes towards the positive and energetic culture
• Fully support Poly-Med’s goals of zero workplace safety incidents and participates in EHS programs
• Performs related duties as assigned.

Required/Preferable Knowledge, Skills and Abilities

• Positive Attitude
• Attention to details
• Time Management
• Ability to listen and communicate effectively.
• Experience in the food service industry is helpful.
• Willingness to learn, listen to directions and accept guidance.

Education/Experience Requirements:

Required: High School Diploma or GED

Environmental Requirements:

Must be able to adapt to multiple indoor work environments (shared office space, shared lab space and production areas).

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

This position will implement product design and process development activities for extruded products with compliance to all quality and regulatory requirements. This is a full-time, on-site position. This role is an Independent Contributor role. There are no direct reports for this position. Interaction is potentially with all levels of the organization.

​Responsibilities for the Extrusion Engineer:

Interface with customers, suppliers, and internal cross-functional team members to develop specifications, coordinate prototype fabrication of customer designed parts, and transition prototypes into manufactured components.

• Project member for new design and development teams of medical fibers, tubes, films, or blend extrusion.
• Provide technical expertise to improve process efficiency/product quality.
• Support new equipment/process implementation.
• Conduct process validation activities following IQ/OQ/PQ techniques.
• Provide cost-saving initiatives by evaluating manufacturing processes while maintaining quality standards.
• Create and analyze prototype products.
• Design experiments to provide data based conclusion about a process or product performance.
• Recommend and rationalize specifications for development products.
• Develop test methods for evaluation of new products following applicable standards such as ASTM or ISO
• Implementation of process improvements and monitoring for efficacy.
• Assist with implementing corrective actions (CAPA) with QA.
• Operate processing equipment in a specific process area.
• Conduct analytical techniques with the ability to interpret results for project recommendations.
• Lead and provide input to risk assessment activities such as FMEA.
• Assist in creation of publishable research findings in the form of abstracts, papers and grants.
• Support patent filing and claims.
• Write technical reports detailing procedures, outcomes, and observations.

Required/Preferable Knowledge, Skills and Abilities for Extrusion Engineer:

• Must have experience with extrusion and fiber processing techniques for single or twin screw extrusion.
• Prior experience with medical fibers and textiles preferred, especially bioabsorbable/bioresorbable materials.
• Prior experience working in an ISO 9001, ISO 13485, or GMP facility.
• Ability to handle confidential business information.
• Understanding of statistical methods and associated statistical analysis software. Preferred experience with Minitab
• Understanding of cause-effect relations between process inputs and product specifications.
• Understanding of the effect of a process on downstream steps or customer needs.
• Ability to design experiments and evaluate data using polymer, fiber, and textile characterization techniques (tensile, burst, tear, porosity, DSC, GPC, viscosity, MFI, melt rheology etc).
• Ability to be a team player.
• Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.

Education/Experience Requirements for Extrusion Engineer:

Required- Bachelor’s Degree with 1 – 3 years industry experience

Working Conditions at Poly-Med, Inc.:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals. Employees must be able to adapt to indoor work environment. The following physical requirements can include: sitting, standing, walking, climbing/balancing, reaching, stooping/kneeling/crouching/crawling, talking, hearing, feeling/touching, vision (close, peripheral, depth, ability to adjust focus).

Poly-Med, Inc. offers a great selection of benefits including vacation time.

Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

The Process IE Engineer is a multi-functional role that will lead production planning activities in close cooperation with manufacturing, sales, purchasing and other functions. Based on information and sales/management input, the Planner develops weekly, monthly, and/or quarterly production plans to achieve revenue and inventory targets. The position primary role will be to direct and perform process improvements in current business environment and assists in the introduction of new processes into new or existing business processes at all levels. This position will make detailed observations and analyses, resolves issues, improves documents, and proposes and implement and document process improvement opportunities.

Responsibilities:

• Plan, coordinate, and communicate production schedules.
• Plan production orders to meet customer ship dates.
• Meet with production personnel to communicate production plan.
• Plan Engineering runs to support development and validation work.
• Schedule equipment and coordinate resources with appropriate manager or designee to produce products while minimizing waste and improving efficiency.
• Collaborate with Procurement to ensure purchase and receipt of raw materials and packaging materials needed to deliver quality product on time.
• Communicate with Business Development regarding acceptance of orders and requested ship dates.
• Coordinate with Maintenance on Preventative Maintenance (PM) work that needs to be completed on production and production support equipment.
• Manage (create, plan, adjust) work orders based on Production and Engineering needs.
• Coordinate Work Order status with Quality (i.e., printing, releasing, lot approvals).
• Coordinate with Inventory and Shipping for on time shipments.
• Review and audit BOM to include work center setups and accuracy of parts/usage.
• Develop reports to show production results vs. plan both for units and cost.
• Enhance the usage of the current EIQ EPR system
• Develop reporting and forecasting for equipment and manpower capacity planning.
• Track and report operational lead-time vs. actual in all parts of the process and supporting processes.
• Maintain Safety as a value in conducting daily responsibilities, responding to production team needs, and developing and implementing process improvements for safety, quality, waste, cost, and productivity improvement.
• Work with cross-function teams to coordinate and implement corrective actions.
• Help maintain pricing models for products.
• Support process trials and ensure successful transfer of projects moving from lab to pilot then to full scale production.
• Provide manufacturing support to the capital project engineer to ensure successful startup of new equipment. This also includes participating in scope and safety reviews, writing, and training on operations procedures and coordinating pre-startup safety reviews/tracking of action items.
• Track and implement process improvements for improving capacity/throughput.
• Track production downtime and cycle times, lead and participate in root cause analysis for production and quality and maintenance system failures. Complete corrective actions to prevent re-occurrence.
• Develop operations procedures needed for operations training program.
• Perform additional duties as assigned by management.

Required/Preferable Knowledge, Skills and Abilities

• Strong detail oriented and the ability to follow documented procedures.
• Experience in a manufacturing environment and able to understand the process flows.
• Ability to operate and be effective with a minimum of direct supervision.
• Ability to work effectively with time pressures and multiple changing priorities.
• Team player
• Dependable
• Strong math skills and computer skills, primarily MS Excel and Word
• Experience in an ERP system is preferable.
• Experience with MS Project is preferable.
• Must be able to utilize/view a PC and/or monitor.
• Develop either/or Crystal reporting of BI reporting for operational controls.
• Project management skills
• Strong communication skills, both written and verbal with the ability to communicate effectively with all levels of the organization.
• Able to manage multiple projects/tasks and adjust priorities, as necessary.
• Must have a high attention to detail and organizational skills necessary to progress on multiple projects simultaneously.
• Able to establish and sustain effective relationships with all stakeholders to foster an environment where innovation and cooperation are used to solve problems.
• Able to influence others through demonstrated competence and respect with data and facts.
• Proficiency with Microsoft Office applications (Outlook, Word, Excel, PowerPoint)

Education/Experience Requirements:

Required: Bachelor’s Degree in Industrial Engineering Degree and/or with equivalent Industrial / Process Development experience and 1-3 years of industry IE experience.

Preferred: Experience in chemical manufacturing relating to pharmaceuticals or medical devices preferred, Green belt certification preferred. PMP (Project Management Program) Certification

Environmental/Physical Requirements:

Must be able to adapt to multiple indoor work environments (shared office space, shared lab space and production areas). Must be able to walk, bend, stoop, crawl, push, and reach for extended periods of time.

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

The Quality Control/Analytics Technician is an entry-level position requiring one or more years of relevant experience. This role will perform testing on absorbable polymeric components for medical device applications.

Responsibilities:

• Perform mechanical and analytical testing of polymeric materials for QC, direct customer requests or for internal projects.
• Write internal memos, reports, and other documents as needed.
• Perform other Quality Control and QA functions including calibration, daily environmental monitoring, and other activities to ensure compliance to GMPs and ISO 13485.
• Seeks resolution to issues encountered during the course of routine testing.
• Perform unbiased, in-process, and finished goods testing according to standardized procedures as required to support product realization.
• Support safety initiatives and compliance.
• Perform lab housekeeping and organization as needed.
• Additional duties may be required as assigned by management.

Required/Preferable Knowledge, Skills and Abilities:
Minimum Associate Degree in Chemistry and 1 year laboratory experience.

Experience with HPLC, GPC, GC, Inherent Viscosity, Tensile testing, DSC, TGA, and/or FTIR preferred.

• Dependable
• Detail oriented
• Organized and efficient
• Ability to follow written and verbal instructions with repeatable and accurate results
• Excellent communication and data recording ability
• Strong math skills and ability to perform calculations as needed
• Must be very detail-oriented and appreciate the value of accuracy
• Ability to deal effectively with time pressures, stress, and changing demands of job on a regular basis.

Working Conditions at Poly-Med, Inc.:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Poly-Med, Inc. (PMI) is seeking an experienced Quality Engineer, preferably with medical device, pharmaceutical or similarly cGMP/ISO regulated industry experience. This position is entry level responsible for performing Quality Engineering tasks and activities with mentoring, guidance and supervision. Has some knowledge of commonly used concepts, practices, and procedures within quality assurance field. Elevates issues to more senior team members to help with judgments to perform primary job responsibilities.

Scope:

This role is an Independent Contributor with no direct reports. Interaction is potentially with all levels of the organization. Progression path would be to Quality Engineer II and then to Senior QE based on performance, development, and experience. This position reports to a Quality Engineering Lead and/or Quality Manager.

Responsibilities for Quality Engineer:

• Participates as Quality Representative on product Design and Development teams giving engineering input as well as regulatory perspective and PMI procedure requirements. May require creation of documents, review of proposals and procedures, and other tasks as assigned by the project manager. Works closely with the project team and manager to ensure project deadlines are met as well as requirements of each phase checklist.
• May participate in validation teams or provide statistical analysis and sample plans as requested.
• Participates in customer and regulatory audits as well as internal audits. When trained may be lead internal or external auditor. Some travel may be required for supplier audits as needed.
• Supports compliance to Good Documentation Practices in document review and acceptance.
• Responsible for enforcing ISO 13485 and cGMP compliance.
• Meet annual Quality Objectives as set with Quality Manager as well as assigned Quality metrics.
• Recommends and implements Quality process improvements with the approval of Quality Manager.
• Perform additional duties as assigned.

Required Knowledge, Skills and Abilities for Quality Engineer:

• Fluency with Microsoft Office Software (Microsoft Word, Excel, et. al.)
• Excellent technical writing skills, grammar, proof reading skills
• Excellent organizational skills, attention to detail, ability to manage time and prioritize
• Ability to think proactively, troubleshoot, investigate and improve systems
• Excellent communication and interpersonal skills, able to assertively interact with people at all levels of the organization
• Ability to lead projects and train others as required
• Ability to handle confidential business information

Education/Experience Requirements for Quality Engineer:

• Required – Bachelor’s Degree in chemical, plastics or polymer engineering.
• Preferred – At least 1 year experience in medical device, pharmaceutical or similarly cGMP/ISO regulated industry

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

Position Summary:

Poly-Med, Inc. is seeking candidates that have experience with working in a fast paced environment, motivated, enthusiastic, and works well in both a team and individual setting. Our polymer manufacturing technicians play a critical role in the manufacturing process of creating our products. Candidates with experience in restaurants as either a waiter or waitress will make the ideal candidate.

Responsibilities:

• 21 CFR part 11 compliance
• Code auditing and securing, code control
• GUI testing, Web testing, Regression testing, User Acceptance Testing, Functional Testing, System Testing, Integration Testing, End to End Testing, Unit Testing
• Software Development Life Cycle (SDLC), Software Testing Life Cycle (STLC)
• Continuous Integration of the automation framework
• Implementing functional tests
• User Acceptance testing (UAT), End to End, Sanity Testing, Functional Testing, Regression Testing, Validation Testing, Performance Testing, black box, white box and Cross – Browser testing
• User Acceptance Testing (UAT) and Interacting with Business Owners for validations
• Troubleshooting software applications, reviewing code and look for errors
• Test Plan, Test Cases and Testing Procedures, which included Test Cases/Scripts, capturing Test Results and capturing and resolving Test Anomalies
• Design, coding, project planning and system technical documentation on C#.
• Developing the custom controls and user controls
• Analyzing User and Functional requirements to point out gaps
• Medical device/pharma electronic batch records

Required/Preferable Knowledge, Skills and Abilities

• Knowledge and practical use of 21 CFR 820 Part 11, specific to system validations to discern invalid or altered records and data storage, integrity, and security
• Ability to test and implement process automation including designing and executing software validations
• Leadership skills to train and educate groups across the company
• Technical writing for writing and reviewing accuracy of documentation associated with automated equipment and processes

Education/Experience Requirements:

Education: Bachelor’s of Science, Computer Science or Software Engineering or related degree

Years of Experience: 3

• Technical proficiency in programming or coding (e.g. Ladder Logic or Structured Text) with an understanding of how to modify/analyze existing programming, detect changes, and assess risks associated with changes or updates
• Primary experience in the Change Control process for software associated with automated equipment
• Analytical, troubleshooting, and critical thinking skills to solve problems
• Ability to communicate technical information effectively processes, procedures, equipment, or training

Environmental Requirements:

• Teamwork- develops and maintains positive working relationships with others, works well in groups
• Communication- communicates appropriately and effectively
• Leadership- self-motivated, has credibility with peers and senior managers, acquires knowledge/skills as the business develops

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.

The Quality Engineer position is responsible for Quality Engineering design activities in support of product design and development. Will function as a team member on design teams to develop and improve products, manufacturing processes, qualification methods for attributes such as Design Control and Risk Management by defining applicable standards, testing criteria, statistical sampling criteria for devices, and manufacturing procedures. Has knowledge of commonly-used concepts, practices, and procedures within the Quality Assurance field. Relies on personal quality engineering experience and judgment to perform primary job responsibilities supporting design and development teams.

This role is an Independent Contributor, and interaction is potential with all levels of the organization providing leadership, training, and coaching support to the design team in coordination with other engineering and business disciplines throughout the product lifecycle process. This position reports to a Quality Team Lead.

Responsibilities of a Quality Engineer:

• Represent the PMI Quality and regulatory compliance position (21 CFR 820 and ISO 13485) in product design and development project scoping, planning, documentation, and execution.
• Strong knowledge, understanding, and experience implementing 21CFR820 and ISO13485.
• Review and approve validation plans and protocols related to equipment, software, process, facility, and cleanroom related protocols
• Contribute to updating QMS as necessary to support medical device requirements for new territories, as well as product life cycle and regulatory review stages.
• Work with all departments in implementing and complying with Quality Systems and cGMP requirements
• Responsible for document management related to the assigned product such as batch cards, MIs, DHF, DHR, DMR, DMF, CAPA, ECO, validations, IP/PS, customer complaints, FMEA, customer proposals, drawings, Design Control, SDS, calibrations, NCR, product shipping and label control
• Monitor compliance by performing internal audits, and review, modification, and approval of standard operational procedures (SOPs); report results to executive management
• Participate in customer and regulatory audits as well as internal audits as required. (Maybe lead Audit, depending on experience and training. Limited travel may be required.)
• Support ISO 14971 and ISO 10993 activities.
• Meet annual Quality Objectives as set with the manager as well as assigned Quality metrics.
• Recommend and implement Quality process improvements with the approval of the Quality Manager.
• Perform validations, participate in validation teams, or work on equipment validation as required by the project.

Required Knowledge, Skills, and Abilities of a Quality Engineer:

• Minimum of 5 years of experience with quality system management in the medical device industry
• Experience on medical device design and development teams and ISO 13485:2016
• Experience authoring risk management documentation per ISO 14971
• Expertise with process validation, automated processes, computer validation and 21 CFR part 820
• Familiarity with Clean Room compliance and practices
• Experience with current Good Manufacturing Practices
• Team player with excellent interpersonal skills
• Fluency with Microsoft Office software (e.g. Microsoft Word, Excel, etc.)
• Excellent technical writing skills, grammar, proofreading skills
• Excellent organizational skills, attention to detail, ability to manage time, and prioritize
• Ability to think proactively, troubleshoot, investigate and improve systems
• Ability to lead projects and train others as required
• Ability to work in a fast-paced team environment
• Ability to work with limited supervision, superior attention to detail, excellent grammar, and proofreading skills
• Excellent communication and interpersonal skills, able to assertively interact with people at all levels of the organization
• Ability to handle confidential business information

Education/Experience Requirements for a Quality Engineer:

Bachelor’s degree in engineering preferably biomedical, textile, chemical, plastics, or polymer engineering with at least five (5) years of Quality engineering experience in a high volume medical device and/or pharmaceutical industry.

Working Conditions at Poly-Med, Inc.

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans