Senior NPD Process Engineer – Medical Devices

Automatic Data Processing, Inc.; Plymouth (MN); On-site; USD 115,000 - 152,000; Full time

Benefits offered by this job

401k with company match

Medical Insurance

Health Savings Account/Flexible Spend

Job summary

ProMed is seeking a Principal New Product Development Process Engineer to transform new medical device concepts into scalable manufacturing processes. You will lead process development, validation, and technology transfer with cross-functional teams to ensure quality and regulatory compliance.

You will mentor engineers, drive process improvements, and partner with Engineering, Manufacturing, Quality, Tooling, and Operations to enable successful product launches and long-term production readiness.

Qualifications

• Requires Bachelor's degree in an engineering discipline and 10+ years in process development or medical device manufacturing.
• Demonstrated success leading complex engineering initiatives and process validation with IQ/OQ/PQ.
• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, risk management, and quality systems.

Responsibilities

• Develop manufacturing processes transitioning concepts to production readiness.
• Lead DOE, validation strategies, and design for manufacturability with cross-functional teams.
• Provide technical leadership and mentorship to engineers with minimal supervision.
• Collaborate across Engineering, Manufacturing, Quality, and Supply Chain to ensure product transfer.
• Develop and maintain engineering documentation supporting regulatory compliance.

Skills

Manufacturing process development

Design of Experiments (DOE)

Process validation

Statistical analysis

Regulatory compliance

Mentorship

Independent problem solving

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Plastics Engineering

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Chemical Engineering

Job description

ProMed is seeking a Principal New Product Development Process Engineer to transform new medical device concepts into scalable manufacturing processes. You will lead process development, validation, and technology transfer with cross-functional teams to ensure quality and regulatory compliance.

You will mentor engineers, drive process improvements, and partner with Engineering, Manufacturing, Quality, Tooling, and Operations to enable successful product launches and long-term production readiness.