Design Assurance Engineer

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. Headquartered in Marlborough, MA, we aspire to work together with our employees and customers to apply light in ways that improve life.

Our mission is to develop innovative medical device laser solutions that make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged, diverse, and thriving workforce that drives a sustainable future for our company and society.

Working at IPG Medical Group you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

Job Summary

The Senior Design Assurance Engineer plays a critical role in ensuring that IPG's medical device products meet regulatory requirements, quality standards, and customer expectations. This position provides technical expertise and leadership in design controls, risk management, and compliance testing throughout the product lifecycle. The Senior Design Assurance Engineer partners closely with cross-functional teams-including R&D, Regulatory, and Manufacturing-to maintain robust design assurance practices, support regulatory submissions, and drive continuous improvement. This role requires deep knowledge of medical device regulations and standards, strong analytical skills, and the ability to balance technical detail with strategic quality objectives.

Key Responsibilities

• Lead and conduct product design control activities for both new product development and sustaining engineering projects.
• Support risk analysis activities, including development and maintenance of design and process FMEAs.
• Partner with cross-functional teams to support design and process validation/verification activities, including software validation and IQ/OQ/PQ protocols.
• Collaborate with Design Engineering to create and maintain Design History Files and Technical Files.
• Coordinate with third-party test houses to ensure compliance testing for IPG products is properly executed and documented.
• Assist the Regulatory Affairs department in preparing FDA, CE, and other global regulatory submissions.
• Ensure adherence to applicable regulatory requirements, company policies, and quality standards.
• Perform other essential duties as assigned to support departmental and organizational objectives.