Title: Senior Design Assurance Engineer
Location: Marlborough, MA (On-Site)
A MA-based company that develops innovative medical device laser solutions is rapidly growing and seeking additional support on their Quality team. They are looking for a Senior Design Assurance Engineer to lead NPD activities from start to finish as they continue to create new products.
Responsibilities:
- Conduct product design control activities for both new and ongoing product development projects.
- Support risk analysis efforts, including design and process Failure Modes and Effects Analysis (FMEA).
- Assist with Process/Design Validation and Verification activities, including software validation and Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
- Aid Design Engineering in creating Design History and Technical Files.
- Coordinate with third-party test houses for compliance testing of IPG products.
- Assist the regulatory department with submissions to the FDA, CE, and other regulatory bodies.
- Perform other essential duties as assigned.
Qualifications:
- Bachelors degree with 7+ years of experience within medical device
- Experience working with a product from design to commercialization
- Expertise with design controls and risk management
- Must be authorized to work in the US without sponsorship
If this sounds interesting, please apply for more information!
