Senior TPM Engineer, Medical Devices (Onsite)

I3 INFOTEK INC; Minnesota; On-site; USD 110,000 - 140,000; Full time

Job summary

I3 INFOTEK INC in Plymouth, MN seeks a Third Party Manufacturers Engineer (TPM Engineer) with medical device experience for 100% onsite role. You will lead manufacturing projects with TPMs, oversee scope, cost and schedule, and ensure compliance with FDA, ISO, ASTM, and USP.

The ideal candidate has 5+ years in manufacturing engineering, strong cross-functional collaboration, and data-driven problem solving. Excellent communication with stakeholders and senior management is essential.

Qualifications

• 5+ years of manufacturing engineering experience in medical device industry.
• 3–5 years of leading projects involving Third Party Manufacturers (TPMs).
• Ability to independently manage scope, cost, and schedule.

Responsibilities

• Lead and manage TPM-related projects, including scope, cost, and schedule.
• Collaborate with cross-functional, global teams on complex TPM initiatives.
• Apply data-driven analysis to drive improvements in medical device manufacturing.
• Engage stakeholders and senior management through clear communication.
• Navigate regulatory considerations (FDA, ISO, ASTM, USP) in projects.

Skills

Manufacturing engineering

Project leadership

Regulatory knowledge

Job description

I3 INFOTEK INC in Plymouth, MN seeks a Third Party Manufacturers Engineer (TPM Engineer) with medical device experience for 100% onsite role. You will lead manufacturing projects with TPMs, oversee scope, cost and schedule, and ensure compliance with FDA, ISO, ASTM, and USP.

The ideal candidate has 5+ years in manufacturing engineering, strong cross-functional collaboration, and data-driven problem solving. Excellent communication with stakeholders and senior management is essential.