Senior Design Assurance Engineer- Maple Grove MN

Senior Design Assurance Engineer - Maple Grove MN - Class II Devices Join Our Client's Innovative Team!

Are you ready to take your engineering career to the next level? Our client, located in the vibrant Maple Grove area, is seeking a skilled and driven Senior Design Assurance Engineer to contribute to the development of Class II medical devices. If you are passionate about driving quality and innovation while working with a forward-thinking team, this could be the perfect opportunity for you!

• Champion the creation and implementation of design control deliverables.
• Lead Design Verification, Design Validation, and support Process Validation (IQ/OQ/PQ/PPQ).
• Translate user requirements into measurable, verifiable product requirements.
• Oversee risk management throughout the device lifecycle, from concept to post-launch.
• Develop accurate and repeatable test and inspection methods.
• Support biocompatibility and sterilization qualifications.
• Analyze data and prepare comprehensive product test reports.
• Ensure completeness and integrity of the Design History File.
• Define and evaluate component specifications through sampling plans and inspections.
• Collaborate with suppliers and participate in external audits.
• Support manufacturing teams by addressing components or manufacturing barriers promptly.
• Lead root cause analysis to drive effective resolutions.

• Strong expertise in design control deliverables and risk management activities.
• Proven experience with Design Verification, Validation, and Process Validation.
• Analytical mindset with proficiency in data analysis and test report preparation.
• Ability to work collaboratively and effectively in cross‑functional teams.

If you're ready to bring your expertise, help innovate life‑saving medical technologies, and join a passionate team, don't miss this opportunity. Apply today!

EOE Statement: Specialist Staffing Group 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 veteran status.

In addition to base pay, direct‑hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.