Careers

The Quality Engineer position is responsible for performing Quality Engineering tasks and activities with some guidance and supervision. Has knowledge of commonly used concepts, practices, and procedures within quality assurance field. Relies on personal engineering experience and judgment to perform primary job responsibilities supporting design and development teams. This role is an Independent Contributor with no direct reports. Interaction is potentially with all levels of the organization. Progression path would be to a senior level Quality Engineer based on performance, development, and experience. This position reports to a more senior Quality Engineer, Assistant Manager or Quality Manager.

Responsibilities for Quality Engineer:

• Participates in design and development project meetings as the Quality representative supporting regulatory compliance and PMI Quality position in product design and development documentation.
• Supports compliance to Good Documentation Practices during assigned document reviews.
• Responsible for document management related to assigned product such as batch cards, MIs, DHR, DMR, DMF,CAPA, ECO, Validations, IP/PS, customer complaints, FMEA, Customer Proposals, Drawings, Design Control, SDS’, Calibrations, NCR, Product shipping and Label Control.
• Participates in customer and regulatory audits as well as internal audits as required. When trained may be internal or external auditor. For this some travel may be required.
• Responsible for the ISO 13485 and cGMP compliance of the assigned projects and programs.
• Meet annual Quality Objectives as set with manager as well as assigned Quality metrics.
• Recommends and implements Quality process improvements with the approval of Quality Manager.
• Perform validations or participate in validation teams or work on analytical equipment validation as required by project.

Required Knowledge, Skills and Abilities for Quality Engineer:

• Fluency with Microsoft Office Software (Microsoft Word, Excel, et. al.)
• Experience with Minitab
• 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.

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.

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.

This position will involve R&D project activities with compliance to all quality and regulatory requirements. This is a full-time, on-site position in a hands-on laboratory and manufacturing environment. 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 Role:

• Design products, prototypes, equipment or fixtures using 3D CAD design software.
• Operate processing equipment in a specific process area, including but not limited to mechanical testing equipment and machining support equipment.
• Design experiments to provide data based conclusion about a process or product performance.
• Perform/coordinate characterization testing as needed for part characterization (ex. mechanical testing) and communicate results to project stakeholders.
• Procure and implement new testing and manufacturing equipment using IQ/OQ/PQ validation techniques.
• Conduct/support process development activities.
• Assist in project tasks planning, management, coordination and execution.
• Using GDP practices, maintain laboratory notebook and write technical reports detailing procedures, outcomes, and observations.
• Assist in creation of publishable research findings in the form of abstracts, papers and grants.
• Recommend and rationalize specifications for development products.
• Support patent filing and claims.
• Interface with cross-functional team members to develop specifications, coordinate prototype fabrication, and transition medical device prototypes into manufactured components.

Required/Preferable Knowledge, Skills and Abilities for the Role:

• Prior hands-on experience with 3D CAD design software (including, but not limited to, SOLIDWORKS).
• Prior hands-on experience with mechanical testing equipment, fixture design, and test method execution.
• Prior experience with drafting drawings for machining purposes with associated tolerances and specifications.
• Prior experience with surface characterization techniques (ex. surface profilometry, imaging).
• Prior experience with machining and finishing techniques (ex. CNC, polishing).
• Prior experience with medical and/or pharmaceutical grade materials preferred, especially bioabsorbable/bioresorbable materials.
• Familiarity with material characterization analytical techniques as inputs for process development and characterization (UV VIS, rheology, GPC, etc.).
• Prior experience working in an ISO 9001, ISO 13485, or GMP facility.
• Prior experience with performing test methods in accordance with USP, FDA, ISO and/or ASTM standards.
• Ability to handle confidential business information.
• Understanding of statistical methods and associated statistical analysis software. Preferred experience with Minitab.
• Understanding of cause-effect relationship between process inputs and product specifications.
• Understanding of the effect of a process on downstream steps or customer needs.
• Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.
• Good written and verbal communication skills, particularly for team communications.

Education/Experience Requirements for the Biomaterials Engineer:

Required- Bachelor’s Degree with 2 years industry experience

Preferred – Bachelor’s Degree or Advanced Degree in Bioengineering or Mechanical Engineering plus industry experience with materials testing and characterization.

Description for Polymer Engineer:

This position involves developing and validating the manufacturing process for various degradable polymers as well as executing product development tasks. 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 Polymer Engineer:

• Develop procedures for the synthesis of R&D and production degradable polymers
• Write and execute validation protocols for pilot and production batches.
• Execute the synthesis of degradable polymers for internal R&D applications and external customers
• Assist with the research and development of approved and assigned projects
• Assist with the development and validation of analytical methods for characterization of polymers
• Evaluates suitability of new raw materials for new or existing products.
• Assists in training personnel for transfer of methods from Engineering Solutions to production.
• Troubleshoot issues during polymer manufacturing, acting as first responder to issues with equipment or process.
• Build and test prototypes, both hands-on and via coordination with support functions and demonstrate full knowledge of the documentation that governs these operations. (e.g. Standard Operating Procedures, Manufacturing Instructions, Log Books, etc.)
• Assists in the scale-up of new or modified formulations to production-size batches and troubleshooting in Manufacturing at the request of operations management.
• Assists Quality and Regulatory Affairs in providing required documentation for submissions.
• Perform data analysis, determine root cause of failures, and provide recommendations to engineering staff
• Collaborate with operations, quality control, engineering, facilities and maintenance personnel to realize goals
• Execute equipment and process qualifications
• Create and maintain clear documentation of experiments and manufacturing process instructions
• Record and maintain documentation in support of Quality System
• Additional duties and responsibilities as assigned by management.
• Preferable Knowledge, Skills and Abilities
• Understanding of polymer synthesis, scale-up and process validation.
• Ability to handle confidential business information.
• Understanding of statistical methods and associated statistical analysis software.
• 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.
• Utilization of Microsoft Office (Excel, Word, PowerPoint) for project execution and internal communication purposes.

Education/Experience Requirements for Polymer Engineer:

Required- Bachelor’s Degree in Chemistry, Chemical Engineering, Materials Science and Engineering or related field

Preferred- Bachelor’s Degree with 3 years industry experience

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.

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.

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.