Senior NPD Process Engineer, 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 / Flexible SpE

Vision Insurance

Life Insurance

Paid Family Medical Leave

Long-Term Disability Insurance

Hospital Indemnity

Critical Illness

Pet Insurance

Job summary

ProMed Molded Products, Inc. seeks a Principal New Product Development Process Engineer to transform innovative designs into scalable manufacturing workflows.

You will lead process development, validation, and transfer of medical devices, collaborating across Engineering, Manufacturing, Quality, Tooling, and Customer teams to ensure regulatory compliance and production readiness. You will mentor engineers, apply advanced engineering principles, and shape processes that improve quality,

Qualifications

• Bachelor's degree in Mechanical Engineering or related discipline is required.
• Minimum 10 years of progressive engineering experience in process development/manufacturing/medical devices.
• Experience developing and implementing manufacturing processes for new product introductions in regulated environments.
• Strong knowledge of silicone molding, injection molding, tooling design, and automation.
• Familiarity with FDA regulations, ISO 13485, ISO 14971, risk management, and validation methodologies.
• Ability to independently manage multiple priorities and lead cross-functional teams.
• Proven track record of mentorship and guiding engineers to higher standards.
• Excellent communication, technical writing, and problem-solving skills.

Responsibilities

• Lead development of manufacturing processes from concept to manufacturing readiness.
• Design, evaluate, and optimize processes for quality, repeatability, and scalability.
• Act as senior technical resource for new product process development and DOE.
• Provide mentorship and raise engineering standards across the team.
• Oversee process validation strategies, protocols, and documentation (IQ/OQ/PQ).
• Collaborate with Manufacturing, Quality, Tooling, Operations, and Customer teams.
• Identify opportunities to adopt new technologies and improve methodologies.
• Ensure documentation supports successful transfers into production.

Skills

Manufacturing process development

DOE

Statistical analysis

Process validation

Regulatory compliance

FDA regulations

Mentorship

Cross-functional collaboration

Analytical thinking

Documentation practices

Education

Bachelor's degree in Mechanical or related engineering

Tools

SolidWorks

Job description

ProMed Molded Products, Inc. seeks a Principal New Product Development Process Engineer to transform innovative designs into scalable manufacturing workflows.

You will lead process development, validation, and transfer of medical devices, collaborating across Engineering, Manufacturing, Quality, Tooling, and Customer teams to ensure regulatory compliance and production readiness. You will mentor engineers, apply advanced engineering principles, and shape processes that improve quality,