This opportunity is with a small device company which is part of a multi-billion dollar parent company in the biotech/biomaterials space. The company is located in the Twin Cities metro area. Residing in the Twin Cities is necessary.
This person will report to the R&D Manager and be the Lead Engineer on projects, as well as coach/mentor to less experienced engineers. Looking for someone who understands proper design controls, well versed in risk management and able to troubleshoot issues.
Ideal candidate will have 6-8 years’ R&D experience in a Product Development role with 4+ years of medical device and design control experience. Must have experience in tissue engineering, biomaterials and polymers and have brought at least 1-2 devices from concept/feasibility through product launch.
The person will support & execute internal and contract product development projects. This position is a key role within the R&D organization ensuring innovative and quality products are delivered in a timely manner while maintaining compliance with industry standards and regulations.
Essential Job Function to include (but not limited to):
- Champion new product development projects: researching, developing and securing regulatory approval for new regenerative medicine products.
- Actively engage and collaborate on global cross functional product development teams.
- Medical Device Design Control and Risk Management
- Independently draft/author all typical design control documentation in accordance with relevant internal SOPs such as: trace matrices, design verification plans and reports, risk documentation, design validation plans and reports, usability reports, final product labeling (including IFUs).
- Independently lead interactions with external vendors such as test labs (e.g. biocompatibility, animal study, and analytical) and suppliers.
- Independently author engineering reports and presentations as required to document and communicate findings.
- Independently research, develop and formulate new products/prototypes.
- Independently design, execute, compile data and draw conclusions for complex experimentation.
- Assist with clinical/user needs assessments.
- Fully knowledgeable of the clinical aspects of the product(s) to be developed, including: disease or anatomical malady, competitive product landscape and unmet needs of the current state of the art treatment(s).
- Assist with intellectual property searches and evaluations.
- Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as appropriate.
- Support sustaining and process engineering efforts during process scale-up and manufacturing improvement initiatives.