Sr. Design Assurance Engineer

Description

The Senior Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.

Skills

Medical device, Design control, Risk management

Top Skills Details

Medical device,Design control,Risk management

Additional Skills & Qualifications

Essential Functions: Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables Accountable for Design Verification and Validation planning and /or, including active cross-functional root-cause analysis investigation & 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; collaboratively communicating & resolving gaps Support and ensure internal & external audit responses and on-time product re-certifications Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications Provide support for biocompatibility and sterilization qualifications Develop and lead other team members and provide work direction as required May have 2-3 technicians assigned for inspection, testing and project support Performs other functions as required

Experience Level

Expert Level

This is a Contract position based out of Fridley, 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 Fridley,MN.

This position is anticipated to close on Apr 30, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $50 - $65