Sr. Design Assurance Engineer

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!