Join Insulet as a Senior Design Assurance Engineer and play a key role in bringing innovative medical device products from concept to commercialization while ensuring the highest standards of quality, safety, and compliance. This position offers the opportunity to collaborate with cross-functional teams, lead risk management and design assurance activities, influence product development decisions, and mentor engineering teams in a fast-paced FDA-regulated environment. Ideal for quality professionals with expertise in ISO 13485, ISO 14971, design controls, and product validation who are passionate about improving patient outcomes through cutting-edge healthcare technology.

Position Overview: The Senior Design Assurance Engineer is responsible for ensuring new products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO 14971. He/she is responsible for maintaining a strong collaborative partnership with cross-functional team members. He/she will serve as a Quality representative to improve awareness, visibility, and communication on all quality initiatives in order to support departmental, functional and corporate quality goals and priorities. He/she can effectively communicate with all levels of the organization.

Join Insulet as a Senior Design Assurance Engineer and play a key role in bringing innovative medical device products from concept to commercialization while ensuring the highest standards of quality, safety, and compliance. This position offers the opportunity to collaborate with cross-functional teams, lead risk management and design assurance activities, influence product development decisions, and mentor engineering teams in a fast-paced FDA-regulated environment. Ideal for quality professionals with expertise in ISO 13485, ISO 14971, design controls, and product validation who are passionate about improving patient outcomes through cutting-edge healthcare technology.

Position Overview: The Senior Design Assurance Engineer is responsible for ensuring new products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO 14971. He/she is responsible for maintaining a strong collaborative partnership with cross-functional team members. He/she will serve as a Quality representative to improve awareness, visibility, and communication on all quality initiatives in order to support departmental, functional and corporate quality goals and priorities. He/she can effectively communicate with all levels of the organization.