Job Title: Design Quality Engineer
Location: Maple Grove, MN (Hybrid position)
12 Months Contract Project
Business 1st Shift (08:00:AM - 04:30:PM)
Job Description:
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.
Key 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