Senior NPI & Process Development Engineer Medical Devices

Resonetics; Fridley (MN); On-site; USD 105,000 - 135,000; Full time

Job summary

Resonetics, a global leader in advanced engineering and micro manufacturing for the medical device industry, seeks a Senior NPI/Process Development Engineer in Minnesota. You’ll develop and validate manufacturing processes for Class 3 active implantable devices and support readiness for commercial production.

The role emphasizes cost, quality, continuous improvement, and strong customer service across cross-functional teams, reporting to the NPI leadership.

Qualifications

• Bachelor’s degree in engineering or related field.
• 5+ years related experience in medical device industry with a heavy focus on product or process development of Active Implantable Devices.
• Experience with process validations for laser welding, header attachment, and internal moisture bake and Test Method Validation for Helium Leak Testing.
• Demonstrated ability to independently develop medical device manufacturing processes from concept to production.
• Experience with medical device Design For Manufacturing, design control, quality systems and product development phases.
• Demonstrated ability to implement change that improves department and company performance.
• Ability to handle multiple projects simultaneously.
• Team player with strong interpersonal skills and cross-functional drive.
• Experience with SolidWorks and/or Mastercam.
• MS Office Proficiency.

Responsibilities

• Develop and validate processes used to manufacture components, sub-assemblies, and finished devices.
• Lead and mentor junior engineers and technicians.
• Act as liaison between development and operations.
• Ensure processes are repeatable and meet design requirements.
• Prepare and present detailed project plans and milestones.
• Coordinate resources, facilities, and equipment for projects.
• Improve production controls, SOPs, safety, quality, and training systems.
• Prepare layouts of buildings and equipment for manufacturing.
• Coordinate manufacturing launches for new or revised products.
• Design, develop, test, and source tools and equipment for manufacturing methods.
• Conduct product/process analysis for production and quality metrics.
• Write engineering change orders to update docs and BOMs.
• Support finance, HR, quality, regulatory, and clinical as needed to ensure compliance.
• Recommend and implement process improvements and new equipment.
• Lead capital expenditure justifications.
• Assist production transfers from R&D to manufacturing.

Skills

Project management

Cross-functional collaboration

Process development

Quality systems familiarity

MS Office

Education

Bachelor's degree in engineering

Tools

SolidWorks

Mastercam

Job description

Resonetics, a global leader in advanced engineering and micro manufacturing for the medical device industry, seeks a Senior NPI/Process Development Engineer in Minnesota. You’ll develop and validate manufacturing processes for Class 3 active implantable devices and support readiness for commercial production.

The role emphasizes cost, quality, continuous improvement, and strong customer service across cross-functional teams, reporting to the NPI leadership.