Sr. Manufacturing Engineer - Medical Device

LCI-Lawinger Consulting • Fridley, MN

4d • Onsite

About The Position

The Senior Manufacturing Engineer is responsible for developing, optimizing, and sustaining manufacturing processes for medical device production. This role drives process improvements, ensures compliance with quality and regulatory requirements.

Requirements

• Bachelor's degree in Mechanical, Manufacturing, Industrial, Biomedical, or related Engineering field.
• 5-7 years of manufacturing engineering experience, preferably in the medical device industry.
• Experience with process validation, Lean manufacturing, statistical analysis, and continuous improvement.
• Working knowledge of FDA regulations, ISO 13485, GMP, and risk management tools.
• Strong problem-solving, project management, and communication skills.

Responsibilities

• Develop, validate, and optimize manufacturing processes and equipment.
• Lead process improvement initiatives using Lean, Six Sigma, and root cause analysis.
• Support new product introduction through process development, qualification, and transfer to production.
• Create and maintain manufacturing documentation, including work instructions, PFMEAs, control plans, and process validations (IQ/OQ/PQ).
• Investigate and resolve production issues using data-driven problem-solving methods.
• Collaborate with Quality, R&D, Supply Chain, and Operations to improve product manufacturability and operational performance.
• Ensure compliance with FDA, ISO 13485, GMP, and company quality system requirements.
• Mentor junior engineers and provide technical leadership on manufacturing projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior