Lead Manufacturing Engineer II — Medical Devices (Class III)

Express Employment Professionals - Edina; Edina (MN); On-site; USD 55,000 - 83,000; Full time

Job summary

Express Employment Professionals - Edina is seeking a Manufacturing Engineer II to support Class III medical device manufacturing in Minnesota. You will own complex engineering initiatives, provide technical leadership, and partner with Quality, Operations, and R&D to improve processes and ensure regulatory compliance.

The role requires hands-on experience with IQ/OQ/PQ, risk assessments, process controls, and supplier changes, plus Lean, Six Sigma, and GMP knowledge.

Qualifications

• Must have previous catheder expereince
• Experience with process validation and regulated manufacturing practices.
• Demonstrated experience managing engineering projects and timelines.
• Strong cross‑functional collaboration and communication skills.

Responsibilities

• Provide manufacturing engineering support for Class III medical device manufacturing operations.
• Lead and take ownership of complex technical manufacturing engineering projects and initiatives.
• Develop, execute, and support process validation activities, including IQ, OQ, and PQ.
• Conduct and support risk assessments and establish appropriate manufacturing process controls.
• Identify and anticipate manufacturing issues and recommend effective technical solutions.
• Apply creative problem‑solving and engineering judgment when established methods or precedent may not exist.
• Manage project timelines, deliverables, priorities, and dependencies across multiple concurrent projects.
• Partner closely with Quality, Operations, R&D, Supply Chain, suppliers, and other cross‑functional stakeholders.
• Manage and support supplier changes and evaluate their impact on manufacturing processes, quality, and related systems.
• Support continuous improvement initiatives utilizing Lean, Six Sigma, GMP and other manufacturing methodologies.
• Participate in technical and peer reviews to confirm engineering approaches, rationale, and verification/validation activities.
• Ensure engineering activities are performed in accordance with applicable quality systems, regulatory requirements, and manufacturing standards.

Skills

Catheder experience

IQ/OQ/PQ

Risk assessment

Process controls

Lean

Six Sigma

GMP

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Electrical Engineering

Bachelor’s degree in Software Engineering

Tools

IQ/OQ/PQ validation tools

Job description

Express Employment Professionals - Edina is seeking a Manufacturing Engineer II to support Class III medical device manufacturing in Minnesota. You will own complex engineering initiatives, provide technical leadership, and partner with Quality, Operations, and R&D to improve processes and ensure regulatory compliance.

The role requires hands-on experience with IQ/OQ/PQ, risk assessments, process controls, and supplier changes, plus Lean, Six Sigma, and GMP knowledge.