Senior Design Assurance Engineer -- Medical Device (Hybrid -- Maple Grove, MN) Contract
Job Description
Job DescriptionOur 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:
• Bachelor’s or master’s degree in engineering, Mathematics, Physics or related field.
• Minimum 5 years of experience in Design Quality Assurance or Product Development Engineering, preferably in medical device development.
• Proven experience delivering successful new product development product quality deliverables in a regulated environment.
• Strong knowledge of Design Controls, Risk Management, and Verification & Validation methodologies.
• Excellent communication and collaboration skills across global teams.
• Experience with ISO 10555, ISO 80369, ISO 7864 is a plus
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:
• Schedule: 08:00 AM - 04:30 PM
• Start Date: 9/22/2025
• Work Setup: Hybrid in Maple Grove, MN
• Contract Length: 12 months