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.