Process Engineer

The Process Engineer is responsible for leading clinical build activities and owning process development deliverables, including process characterization, validation documentation, and support of commercialization efforts. This role partners cross-functionally to develop, optimize, and scale robust manufacturing processes while ensuring quality and regulatory compliance.

• Lead clinical build process development, validation activities, and commercialization support.
• Collaborate with R&D, Quality, Regulatory, Production, Equipment Engineering, Supply Chain, and Marketing to deliver complex projects.
• Develop and optimize manufacturing processes using data-driven methods, including process studies, Six Sigma tools, and material testing.
• Design, coordinate, and analyze complex engineering tests and experiments; summarize results and present findings to technical stakeholders.
• Evaluate process and equipment feasibility and lead capital equipment requests (CERAs).
• Drive process improvements, production goals, and technical problem-solving initiatives.
• Lead cross-functional project teams and manage project scope, timelines, and documentation.
• Train and provide technical guidance to operators, technicians, and engineers.
• Ensure all work complies with quality system and regulatory requirements.

• Bachelor’s degree in Mechanical, Chemical, Biomedical, or related Engineering discipline.
• 5+ years of experience in process or manufacturing engineering.
• Experience with electropolishing processes.
• Proficiency with Keyence and Sensofar measurement technologies.

Mid‑Senior level

Contract

Manufacturing and Engineering

Medical Equipment Manufacturing

Location:

Maple Grove, MN