Sr. Design Assurance Engineer

Design Assurance Engineer

Job Description:

The Senior Design Assurance Engineer is a quality engineer responsible for directly supporting medical device product development from concept through commercialization. This role involves working with cross-functional development teams to establish and maintain design control deliverables, manage risk activities, and ensure DHF compliance, all aimed at delivering the highest quality product to customers.

Responsibilities:

• Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
• Lead and complete Design Verification and Validation planning, including active cross-functional root-cause analysis investigation and resolution activities.
• Lead Risk Management activities from product concept through commercialization.
• Support design test and inspection method development, and lead method validation activities.
• Ensure DHF content integrity, completeness, and regulatory/standards compliance, while resolving any gaps collaboratively.
• Support and ensure internal and external audit responses and on-time product re-certifications.
• Establish and ensure objective, measurable, discrete, and verifiable customer and product requirements.
• Define objective component specifications, develop supplied component sampling plans, and conduct vendor qualifications.
• Provide support for biocompatibility and sterilization qualifications.
• Develop and lead other team members, providing work direction to assigned technicians for inspection, testing, and project support.
• Perform other functions as required.

Essential Skills:

• Medical device product development experience
• Design control expertise
• Risk management proficiency
• BS in Industrial Engineering, Engineering, or Business
• Comprehensive understanding of FDA regulations

Additional Skills & Qualifications:

• Statistical and data analysis skills
• Strong supervisory, management, and leadership experience

This is a Contract position based out of St Paul, MN.

The pay range for this position is $50.00 - $65.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in St Paul,MN.

This position is anticipated to close on Mar 17, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $50 - $65