- Support design and development projects for new products, product changes, and enhancements.
- Generate product characterization efforts and document results through formal design analyses or characterization reports.
- Generate and maintain engineering specifications, BOMs, inspection criteria, labeling, and other product documents.
- Support product development efforts by creating CAD models using SolidWorks and fabricating conceptual and functional prototypes using various methods, including 3D printing.
- Lead engineering investigations related to design, manufacturing, or other systemic issues (NCMR and CAPA support). Generate effective root cause analyses through objective data collection, statistical methods, and standard engineering test methods.
- Assist with day-to-day operations including vendor identification, quoting, purchasing, receiving, and supplier management.
- Bachelor’s degree in biomedical engineering or other relevant engineering discipline.
- Ideal candidate will have 1-2 years of work experience in regulated medical device industry but will consider a recent graduate with medical device internship/co-op experience.
- Experience in component design, manufacturing, materials, and design of test fixtures/equipment.
- Familiar with manufacturing processes typical of finished electronic medical equipment, including molded parts, welding, manual assembly, and automated SMT processes for PCBAs.
- Proficiency in SolidWorks, MS Excel, Word, Visio, PowerPoint.
- Experience in medical device development, design transfer, design for manufacturability (DFM), reliability and cost.
- Understanding of medical device DHF, DMR, and DHR files management and documentation requirements.
Why Join Our Team?
- Entrepreneurial work environment – A growth oriented and collaborative atmosphere in the medical device industry!
- Ability to work with game changing technology
- Competitive compensation and benefits
- Employee Wellness Program