Sr. Design Assurance Engineer

Senior Design Assurance Engineer

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

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

Job Type & Location

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

Pay and Benefits

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).

Workplace Type

This is a fully onsite position in Fridley, MN.