Sr. Design Assurance Engineer

Title: Senior Design Assurance EngineerLocation: 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 ProcessDesign 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 deviceExperience working with a product from design to commercializationExpertise with design controls and risk managementMust be authorized to work in the US without sponsorship If this sounds interesting, please apply for more information!

Created: 2025-02-21