Principal Process Development Engineer

Resonetics • Fridley, MN

1d

About The Position

The Principal Process Development Engineer leads the development, improvement, and implementation of cost-effective, compliant manufacturing processes and methods that meet product specifications and quality standards. The role independently drives projects from process development through manufacturing, serves as a liaison between development and operations, and provides leadership and coaching to engineers and technicians. The position also supports manufacturing launches, production transfers, process improvements, and the implementation of LEAN initiatives.

Requirements

• Bachelor’s degree in engineering or a related field.
• 10+ years of related experience in the medical device industry, focused on process development.
• 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 positively affects department and company performance.
• Ability to handle multiple projects simultaneously.
• Strong teamwork and interpersonal skills, with demonstrated ability to drive results cross-functionally.
• Experience using influence to affect project and organizational success.
• Experience with SolidWorks and/or Mastercam.
• Proficiency with MS Office.
• Ability to handle confidential and/or sensitive information.
• Must already be legally authorized to work in the United States without visa sponsorship now or in the future.

Responsibilities

• Independently develop manufacturing processes for components, sub-assemblies, and finished devices, and drive projects to completion.
• Provide leadership and coaching to less experienced engineers and technicians.
• Act as a liaison between development and operations.
• Ensure processes are repeatable and capable of producing products that meet design requirements.
• Prepare and present detailed project plans, establish schedule milestones, and coordinate project resources, facilities, and equipment.
• Help improve production controls, standard operating procedures, safety, quality control, and training systems.
• Prepare and maintain detailed layouts of buildings and equipment.
• Coordinate manufacturing launches for new or revised products, including setting goals, training team members, and evaluating results.
• Design, develop, test, and source tools, machinery, and equipment for manufacturing methods, and provide return-on-investment analyses.
• Analyze production and quality metrics for products and processes.
• Write engineering change orders for changes to manufacturing documents, drawings, and bills of materials.
• Support finance, accounting, human resources, quality, regulatory, and clinical departments as needed to ensure compliance.
• Recommend, support, and implement improvements, modifications, or additions to work processes.
• Lead analysis of new process development needs, including specifying, ordering, installing, and validating equipment or processes.
• Prepare capital expenditure justifications.
• Support production transfers from R&D to manufacturing.
• Propose new manufacturing technologies, including automation and new equipment.
• Contribute to defining, developing, and implementing LEAN manufacturing initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal