Senior Medical Device Manufacturing Engineer — Lean & PMO

Laborie; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Paid time off

Medical, Dental, Vision

401k with company match

Parental Leave

Wellness programs

Job summary

Laborie is seeking a Senior Manufacturing Engineer to drive development, qualification, and launch of drug-device products into manufacturing. The role collaborates across departments to ensure efficient design transfer, robust processes, and lean improvements.

Responsibilities include shaping production layouts, qualifying processes, leading risk reviews, and supporting validation activities. Travel ~10% domestically/internationally as needed.

Qualifications

• Bachelor's degree in Biomedical, Mechanical, or Industrial Engineering or related field; 5+ years experience (or MS with 3+ years).
• Experience with lean manufacturing methods and procedures.
• Experience in medical device or pharmaceutical environments; production, quality, and product development.
• Strong project management: planning, scheduling, budgeting; strong communication skills.

Responsibilities

• Design manufacturing processes, procedures, and layouts to optimize productivity and cost for drug-device combination products.
• Optimize coating, manufacturing, and packaging processes; improve capabilities and implement improvements.
• Manage schedules, budgets, and risks; report status to stakeholders and leadership.
• Participate in PFMEA/DFMEA, Process Mapping, CTQ reviews; lead DFM activities.
• Support line validation/qualification incl. IQ, OQ, MSA, PQ; author docs and execute tests.
• Participate in Lean initiatives to stabilize lines and reduce waste; analyze costs.

Skills

Lean manufacturing

Project management

Troubleshooting

Communication

Leadership

Team collaboration

Education

Bachelor's degree in Biomedical/Mechanical/Industrial Engineering

Master's degree (preferred)

Job description

Laborie is seeking a Senior Manufacturing Engineer to drive development, qualification, and launch of drug-device products into manufacturing. The role collaborates across departments to ensure efficient design transfer, robust processes, and lean improvements.

Responsibilities include shaping production layouts, qualifying processes, leading risk reviews, and supporting validation activities. Travel ~10% domestically/internationally as needed.