Principal Process Development Engineer

Resonetics•Minneapolis, MN

3d•$118,000 - $186,000

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 production, serves as a liaison between development and operations, and provides leadership and coaching to engineers and technicians. It also supports manufacturing launches, production transfers, equipment and process validation, continuous improvement, and cross-functional compliance efforts.

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 through production.
Experience with medical device Design for Manufacturing, design control, quality systems, and product development phases.
Demonstrated ability to implement change that positively impacts 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 responsibly.
Able to lift up to 25 pounds at times.
Excellent hand-eye coordination.
Ability to differentiate between colored wires, tabs, and electronic components.
Must wear gown, gloves, and ear protection if applicable.

Responsibilities

Independently develop manufacturing processes for components, sub-assemblies, and finished-goods devices, and drive projects to completion.
Provide leadership and coaching to less experienced engineers and technicians.
Act as the liaison between development and operations.
Advocate for processes that are repeatable and capable of producing products that meet design requirements.
Prepare and present detailed plans for assigned projects.
Develop project milestones and coordinate resources, facilities, and equipment.
Assist in improving production controls, standard operating procedures, safety, quality control, and training.
Prepare and maintain detailed layouts of buildings and equipment.
Coordinate manufacturing launches of 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, including providing ROI analysis.
Perform product and process analysis using production and quality metrics.
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 needs for new process development; specify, order, install, and validate new equipment or processes.
Prepare justifications for capital expenditures.
Assist with 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.