Senior Design Assurance Engineer — Medical Device (Hybrid — Maple Grove, MN) Contract

Job Description

Our Fortune 500 Medical Device client has an exciting opportunity for a Sr. Design Assurance Engineer.

Job Summary :

We are seeking a highly skilled and motivated Senior Design Assurance Engineer to serve as the Core Team Lead for a New Product Development of an Introducer Set within the Interventional Oncology & Embolics portfolio. This is a short-duration, high-impact role focused on driving quality and compliance throughout the product development lifecycle. This role is a hybrid or onsite role in the Maple Grove, MN office and supports a global product development team.

Responsibilities :

• Core Team Leadership : Act as the voice of quality on the cross-functional product development team, ensuring design implementation aligns with strategic business objectives and quality standards.
• Design History File (DHF) Ownership : Lead the creation, maintenance, and audit-readiness of the DHF, ensuring all documentation meets internal and regulatory requirements.
• Risk Management : Own and execute the risk management process, including development of Hazard Analyses, Task Analyses, DFMEAs, and Software FMEAs as applicable.
• Verification & Validation (V&V) : Lead planning, execution, and documentation of design verification and validation activities, including protocol development, test execution, and issue resolution.
• Global Collaboration : Work with international teams to align quality deliverables, share best practices, and ensure consistent execution across geographies.
• Regulatory Compliance : Ensure adherence to applicable standards (e.g., ISO 13485, ISO 1497, FDA QSR, EUMDR) and support regulatory submissions as needed.
• Mentorship & Guidance : Provide technical leadership and mentorship to global, cross-functional partners.

Qualifications :

Why This Role Matters :

This position is critical to improve the user procedural experience, a product with strategic importance and accelerated timelines. You’ll be at the forefront of innovation, ensuring that safety, quality, and compliance are embedded from concept to commercialization.

Other Details :

Requirements

Education :