Job Description

Duration: 12 Months Contract (Possible extension)

**On W2 Contract**

Job Description: Hybrid

About the Role:

We are seeking a highly skilled and motivated Senior Design Assurance Engineer to serve as the Core Team Lead for a New Product Development. 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 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 HClientard 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.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Name: Kanika Dureja

Email: kanika.d@ustechsolutionsinc.com

Internal Id: 25-46952

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