Sr. Design Assurance Engineer

Overview

The Senior Design Assurance Engineer is a quality engineer who supports medical device product development from concept through commercialization, working with cross‑functional development teams to establish and maintain design control deliverables, risk management activities, and DHF compliance.

• Create and ensure on‑time execution of Quality Plans for internal development, OEM‑based, Clinical Product Development (CPDP), and design change projects; lead 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, supporting design test and inspection method development, and lead method validation activities.
• Ensure DHF content integrity, completeness, and regulatory/standards compliance; collaboratively communicate & resolve 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.
• Perform other functions as required.

Expert Level in medical device quality engineering, with demonstrable experience in design control, risk management, DHF compliance, design verification & validation, and audit support.

Expert Level.

Contract position based out of Fridley, MN. Fully onsite.

Pay range: $50.00 - $65.00/hr.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital coverage
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

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.