Ensure that Insulet’s medical device products meet quality, safety and regulatory requirements throughout the development lifecycle
Focus on embedded software systems and ensure compliance with applicable standards, regulations and guidance documents
Interface with other Insulet departments and external parties on product development and support
Provide expert guidance on requirements, specifications, design documentation, verification plans, test protocols, and more
Ensure adherence to Design Controls processes and alignment with Insulet Quality System, Quality System Regulation, and ISO 13485 requirements
Support manufacturing process development and qualification activities for new product launches

BS degree in Computer Science, Software Engineering, Electrical Engineering, Mechanical Engineering, Systems Engineering, or equivalent science degree
5-7 years work experience in Design Assurance/Quality/Product Design and Development within an FDA, ISO, or other regulated environment
Experience with Design Controls (FDA 21 CFR Part 820), and Design and Development /Product Realization (ISO 13485)
Experience with Medical Device regulations (IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, and cybersecurity)
Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS)

Senior Software DQA Engineer – Embedded Software

Key skills