Sustaining R&D Engineer

R&D Engineer Eagan, MN 55121

As a Sustaining R&D Engineer – Surgical Solutions, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Leading cross-functional change management projects affecting commercialized products from changes to the design, specifications, materials or manufacturing processes.
• Acts as the design control owner. Owns, maintains and improves product design input requirements.
• Develops and implements new test methods, both internally and with external partners. Ensures product specifications are appropriate, verified and meet associated user needs, both proactively and during supplier-initiated changes.
• Acts as a holistic product expert and supports the cross-functional team with their technical and design subject matter expertise.
• Stays up to date on external regulations / standards and evaluates their impacts. Modifies product or design requirements to remain state of the art.
• Develops and maintains key supplier relationships, developing deep understanding of product composition, manufacturing technologies, packaging components, and qualification strategies.

Your Skills and Expertise To set you up for success in this role from day one, company requires (at a minimum) the following qualifications:

• Bachelor's Degree or higher AND 5 years relevant experience.
• Minimum 3 years working experience with cGMP drugs or medical devices.

Preferred Qualifications

• Master's degree in chemistry, life sciences or engineering or equivalent degrees from an accredited institution.
• 10 years in a private, public, government or military environment working in highly regulated industries, working within structured QMS procedures, cGMP manufacturing experience, test method development and validation, writing or contributing to regulatory submissions, etc.
• Experience with DMAIC (Define–Measure–Analyze–Improve–Control) methodologies for root cause determination and problem solving are highly desired for this role.
• Self-directed, highly detail-oriented professional with demonstrated ability to thoroughly review, interpret, and challenge technical documentation; capable of identifying errors, inconsistencies, and logic gaps while exercising strong cross-functional facilitative leadership.
• Previous experience leading cross-functional change management projects with high levels of interdependency.

Work Locations

• Hybrid Eligible (Job Duties allow for some remote work but require travel to Eagan, MN at 1–3 days per week).
• (Alternate location) Hybrid Eligible (Job Duties allow for some remote work but require travel to Brookings, SD plant at 1–3 days per week).