Senior Design Assurance Engineer

Insulet Corporation

On-sitePosted 26 июля 2026 г.

About the role

Senior Design Assurance Engineer

Insulet Corporation

On-sitePosted 26 июля 2026 г.

About the role

Join Insulet as a Senior Design Assurance Engineer in Acton, Massachusetts, and play a key role in bringing innovative medical device products to market while ensuring the highest standards of quality, safety, and regulatory compliance. This on-site role involves cross-functional collaboration with engineering, manufacturing, and quality teams, leading risk management, design assurance, and product commercialization in a highly regulated environment. We are seeking experienced professionals with expertise in FDA regulations, ISO 13485, and ISO 14971 who can influence product quality, mentor technical teams, and make a meaningful impact on the lives of people living with diabetes.

Responsibilities

Ensure new product introduction quality deliverables are created and properly executed (e.g., Project Quality Plan and Risk Management Plan).
Work with teams to establish measurable, valid product requirements.
Support Risk Management activities from concept through commercialization.
Support DHF content completion, integrity, and regulatory and standards compliance; identify gaps and work with the team to resolve them.
Review and approve design control documentation (plans, protocols, reports) ensuring compliance with the Insulet Quality System, QSR 820, ISO 13485 and ISO 14971.
Provide guidance to ensure country-specific compliance for targeted markets.
Support manufacturing process development and qualification for new product commercialization and product changes.
Provide project direction, coaching, and mentoring for engineering and technical staff.

Responsibilities

Ensure new product introduction quality deliverables are created and properly executed (e.g., Project Quality Plan and Risk Management Plan).
Work with teams to establish measurable, valid product requirements.
Support Risk Management activities from concept through commercialization.
Support DHF content completion, integrity, and regulatory and standards compliance; identify gaps and work with the team to resolve them.
Review and approve design control documentation (plans, protocols, reports) ensuring compliance with the Insulet Quality System, QSR 820, ISO 13485 and ISO 14971.
Provide guidance to ensure country-specific compliance for targeted markets.
Support manufacturing process development and qualification for new product commercialization and product changes.
Provide project direction, coaching, and mentoring for engineering and technical staff.

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