Manufacturing Engineer

About the role

We are looking for a detail‑oriented Manufacturing Engineer to join our fast‑paced medical‑device operation in Minnetonka. The successful candidate will drive process improvements, support production activities, and ensure compliance with FDA and ISO standards.

Key responsibilities

• Develop, optimize, and maintain manufacturing processes for medical‑device production.
• Lead process validation activities, including IQ, OQ, and PQ protocol execution.
• Collaborate with Quality, R&D, Regulatory Affairs, and Production teams.
• Analyze production data to identify cost‑saving and efficiency opportunities.
• Troubleshoot equipment and process issues on the shop floor.
• Create and maintain SOPs, work instructions, BOMs, and process flow diagrams.
• Support equipment qualification, calibration, and preventive‑maintenance programs.
• Ensure adherence to FDA regulations, GMP, ISO 13485, and internal quality standards.
• Participate in CAPA investigations, root‑cause analysis, and corrective‑action implementation.
• Assist with new‑product introductions and transfer from development to manufacturing.

Required profile

• Bachelor’s degree in Mechanical, Manufacturing, Biomedical Engineering or a related field.
• 2–5 years of manufacturing engineering experience in the medical‑device or regulated industry.
• Hands‑on experience with process validation (IQ/OQ/PQ) and regulatory compliance.
• Familiarity with Lean Manufacturing, Six Sigma, or other continuous‑improvement methodologies.
• Strong analytical, problem‑solving, and documentation skills.

Required skills

• Process validation (IQ/OQ/PQ)
• Good Manufacturing Practices (GMP)
• FDA regulatory knowledge
• Lean Manufacturing
• Six Sigma
• Equipment qualification and calibration
• Preventive maintenance planning
• Data analysis and troubleshooting
• SOP and work‑instruction development
• BOM and process‑flow diagram creation