Piper Companies is looking for a Polymer Engineer II responsible for assuring that products are of consistent and high quality by: Assuming responsibility for duties related to the research, development, testing and manufacturing of medical device materials, products or technologies in compliance with GMP and ISO standards and participating on project teams consisting of R&D, Commercialization, Manufacturing, Quality, Regulatory, Business Development and Finance within the PMP/project management process for a Manufacturing Company in Exton, PA.
Responsibilities for the Polymer Engineer II include:
- Identifying and optimizing product/process variables required for maximizing performance at prototype, lab/pilot, and full production scale for thermoplastic/thermoset injection molding and/or extrusion processing
- Assist with the design and engineering specifications of prototype biomaterials, medical devices and instruments from minimal product descriptions
- Develop injection molding processes using scientific injection molding principles
- Monitor and validate existing injection molding processes and molds to develop and execute continuous improvement opportunities
- Develop and perform fabrication processes on a lab-scale level necessary to prototype, sample and evaluate biomaterials and/or related implants or devices
- Plan, construct and implement DOEs and PFMEAs as required to develop or validate new or existing products
Qualifications for the Polymer Engineer II include:
- Bachelor’s Degree in Engineering – (Materials, Plastics, Manufacturing, Biomedical, Mechanical, Chemical), or related field.
- 2-6 years progressive experience in R&D, Process Engineering, Product Development and/or Project Management of medical products and biomaterials, or a related industry.
- Understanding of Injection Molding Design for manufacturing, process conditions, and tooling.
- Experience in equipment and process validations (IQ, OQ, and PQ) and the transfer of new processes and equipment into manufacturing
- Strong experience in Root Cause analysis and incident investigation skills as well as problem solving
- Computer literacy (i.e. Word, Excel, Project, PowerPoint, Outlook, Pro/E or similar CAD system).
- Knowledge of Design for Manufacturing, Design of Experiments, and statistical methods. Working knowledge of Lean Six Sigma methodology preferred.
- Previous experience involving the extrusion and/or molding of polymers a plus.
- Knowledge of medically useful biomaterials (bioresorbable and non-degradable).
- Knowledge of physical and chemical processing techniques. (i.e. melt processing, foaming, machining, sterilization).
- Working knowledge of analytical and mechanical test equipment.
- Knowledge and understanding of ISO, QSR, cGMP regulations and other relevant regulatory and quality requirements – specifically as related to the manufacture of pharmaceuticals and/or medical grade materials
Compensation for the Polymer Engineer II include:
- Salary Range: $80,000 - $90,000
- Full benefits package
Please send resume to Derek Herbine: email@example.com