Senior NPD Process Engineer for Medical Devices

PROMED MOLDED PRODUCTS INC; Plymouth (MN); On-site; USD 115,000 - 152,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account/FSA

Vision Insurance

Life Insurance

Paid Family Medical Leave and Long‑Trm

Job summary

Promed Molded Products Inc. is seeking a Principal New Product Development Process Engineer to transform innovative designs into scalable manufacturing processes.

You will lead design, validation, and optimization to ensure quality, efficiency, and regulatory compliance across projects. You will mentor engineers, collaborate with cross-functional teams, and drive manufacturing readiness through robust process development and validation strategies.

Qualifications

• Requires a bachelor’s degree in an engineering discipline and 10+ years in process development or medical device manufacturing.
• Experience leading manufacturing process development for new product introductions in regulated environments.
• Strong knowledge of DOE, process validation (IQ/OQ/PQ), and risk management.

Responsibilities

• Lead development of manufacturing processes transitioning new medical devices from concept to production readiness.
• Design, evaluate, and optimize processes to improve quality, repeatability, and scalability.
• Provide technical leadership and mentorship to engineers across teams.
• Develop validation strategies, protocols, and documentation for production transfer.

Skills

Manufacturing process development

DOE

Process validation

Statistical analysis

Process capability

FDA regulations

ISO 13485

Medical device

Leadership

Cross-functional collaboration

Project management

Mentorship

Education

Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, Biomedical Engineering, Chemical Engineering, or related

Tools

Minitab

SolidWorks

Job description

Promed Molded Products Inc. is seeking a Principal New Product Development Process Engineer to transform innovative designs into scalable manufacturing processes.

You will lead design, validation, and optimization to ensure quality, efficiency, and regulatory compliance across projects. You will mentor engineers, collaborate with cross-functional teams, and drive manufacturing readiness through robust process development and validation strategies.