Manufacturing Engineer III

Resonetics•Hutchinson, MN

2d•$65,000 - $102,000

About The Position

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger. We are seeking a Manufacturing Engineer III to support day-to-day production operations within a high-performing value stream. This role will provide hands-on engineering support to an assembly line consisting of metal forming, welding, mechanical assembly, and packaging processes. The Manufacturing Engineer III will serve as a technical leader on the production floor, driving process stability, yield improvement, cost reduction, and continuous improvement initiatives while ensuring compliance with medical device quality and regulatory requirements. This individual will partner cross-functionally with Quality, Operations, Supply Chain, and NPI teams to support customer expectations and operational excellence. Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Requirements

5+ years of manufacturing engineering experience, preferably within a regulated medical device or high-precision manufacturing environment.
Experience supporting production assembly lines with metal forming, welding (laser, TIG, resistance, or similar), and/or precision assembly processes.
Demonstrated experience with process validation (IQ/OQ/PQ) and change management in a regulated environment.
Bachelor’s degree in Mechanical Engineering , Manufacturing Engineering, Biomedical Engineering, or related technical field
Strong root cause analysis and data-driven problem-solving capability.
Working knowledge of statistical analysis tools and SPC.
Experience with Lean Manufacturing and continuous improvement methodologies.
Ability to manage multiple priorities in a fast-paced production setting.
Strong written and verbal communication skills

Nice To Haves

Experience in contract manufacturing or high-mix / low-to-medium volume environments.
Six Sigma certification (Green Belt or higher).
Experience with automated assembly equipment and packaging validation.
Customer-facing experience in technical reviews or high-visibility meetings

Responsibilities

Provide daily floor support for metal forming, welding, assembly, and packaging processes.
Troubleshoot process, equipment, tooling, and yield issues using structured problem-solving methodologies (A3, 8D, root cause analysis).
Develop and implement process improvements to drive scrap reduction, cycle time optimization, and OEE improvement.
Own and maintain manufacturing documentation including work instructions, process flow diagrams, PFMEAs, control plans, and validation protocols.
Lead process validations (IQ/OQ/PQ), revalidations, and engineering change implementation.
Support capital equipment selection , installation, and qualification activities.
Partner with Quality Engineering to ensure compliance with ISO 13485 and FDA regulations.
Support nonconformance investigations, CAPA activities, and customer complaint root cause analysis.
Analyze process capability (Cp/ Cpk ) and drive corrective actions to improve performance.
Ensure robust in-process controls and inspection methods are implemented and sustained.
Promote a culture of safety and adherence to environmental, health, and regulatory standards.
Ensure processes meet EHS, OSHA, and internal safety requirements.
Participate in risk assessments and mitigation planning for new and existing processes.
Conduct work professionally and maintain a high standard of performance and behavior.
Collaborate effectively in a cross-functional team environment.
Mentor junior engineers and technicians in structured problem solving and process discipline.
Train production personnel on new or revised processes and support standard work implementation.