Senior Quality Engineer - Medical Device R&D

Senior Quality Engineer – Drive Innovation in Catheter Manufacturing (Twin Cities, MN)

Are you a Quality Engineer with a passion for bringing cutting-edge medical devices from prototype to production? Do you thrive in an environment where your expertise in validation and statistical analysis directly impacts product success?

Our client, a leading Catheter CDMO in the Twin Cities, is seeking a Senior Quality Engineer to be the onsite quality anchor within their dynamic R&D/Prototype Center. This role is perfect for an independent, customer-facing engineer ready to own the quality framework for next-generation catheter technologies.

This is an exciting, highly autonomous role focused on the upstream quality engineering required for new product introduction (NPI). You will be the primary quality contact, working hand-in-hand with development engineers and customers as products move through the R&D pipeline.

• Process & Test Method Validation: Spearhead and contribute to qualification and validation activities (IQ/OQ/PQ) required for manufacturing process release and transfer, with a strong emphasis on Test Method Validation
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• Statistical Analysis Expert: Apply your deep knowledge of statistical tools, including Gage R&R,
  Root Cause Analysis (RCA), and Statistical Process Control (SPC) (e.g., Minitab), to ensure process capability and reliability.
• Customer-Facing Partner: Act as a technical quality liaison, primarily via email, to external customers during the prototyping and development phase.
• QMS & Compliance Champion: Promote and uphold strong GMP, GDP, and QMS principles, contributing to internal audit effectiveness.
• Independent Leadership: As the sole QE onsite, you will manage the site’s quality engineering needs and direct the work of two inspectors. Your manager provides remote support and rotates between the three sites.

• 5+ Years of Quality Engineering experience within the medical device manufacturing industry (ISO/FDA regulated environment).
• Proven expertise in Process Validation and Test Method Validation
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• Strong command of Statistical Analysis techniques (Gage R&R, RCA, SPC).
• Demonstrated customer-facing communication skills, comfortable supporting development teams and external partners.
• Ability to work independently and manage the quality function on-site with minimal direct supervision.

• Previous experience with Class II or Class III medical devices.
• Direct experience with catheter or shaft manufacturing/extrusion.
• Background working within a CDMO or small OEM environment.

• Competitive starting salary up to $115K based on experience.
• Eligibility for an 8% annual bonus
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• Great Work-Life Balance: Enjoy a 4.5-day work week (M-Th, 9-hour days; F, 4-hour shift).

This role is primarily based at the New Hope, MN facility. Occasional, limited travel will be required to our sister sites in Maplewood and potentially Cokato.

If you are ready for a challenging and rewarding role where you can truly influence the quality foundation of innovative medical devices,
Apply Today!

• Mid-Senior level

• Full-time

• Quality Assurance

• Medical Equipment Manufacturing