Senior Manufacturing Engineer

We are looking for Senior Manufacturing Engineer for our client in

Plymouth, MN Job Title:

Senior Manufacturing Engineer Job Location:

Plymouth, MN Job Type:

Contract Job Overview:

Responsible for leading manufacturing engineering activities focused on catheter manufacturing processes, yield improvement, process optimization, and new product introduction. The role involves driving continuous improvement initiatives, supporting production scale-up, and ensuring compliance with medical device quality and regulatory standards.

Requirement/Must Have:

Bachelor s degree in Mechanical, Chemical, Biomedical, or related engineering discipline or equivalent experience. Minimum five years of manufacturing engineering experience in manufacturing or process development. Strong analytical, problem-solving, and project management skills. Demonstrated ability to work in cross-functional team environments. Ability to lead initiatives and drive process improvements. Strong communication and collaboration skills. Ability to travel up to 25 percent, including international travel. Experience in medical device manufacturing.

Experience:

Experience in catheter or medical device manufacturing processes. Experience supporting new product introduction and process scale-up. Experience in yield improvement and manufacturing process optimization. Experience working in regulated environments such as FDA and

ISO 13485.

Experience in root cause analysis and structured problem-solving methodologies.

Responsibilities:

Lead yield improvement initiatives across catheter manufacturing processes including reflow, assembly, soldering, bonding, and packaging. Apply structured problem-solving methods such as DMAIC, Root Cause Analysis, and A3 to resolve manufacturing issues. Analyze manufacturing data to identify trends and process improvement opportunities. Serve as technical subject matter expert for catheter manufacturing processes and equipment. Coordinate design, procurement, build, and debugging of tooling and test equipment. Support new product introduction and technology transfer from R D to manufacturing. Collaborate with Quality, R D, Supply Chain, Operations, and Regulatory teams. Ensure compliance with

FDA, ISO

13485, GMP, and internal quality systems. Provide technical guidance during investigations and process improvement initiatives. Lead cross-functional project teams and drive accountability for deliverables. Mentor and coach junior engineers and technicians.

Should Have:

Experience in pilot builds and ramp-to-production environments. Experience leading cross-functional manufacturing improvement projects. Strong leadership and mentoring capabilities. Ability to work in fast-paced manufacturing environments. Strong attention to detail and data-driven decision-making mindset.

Skills:

Manufacturing process engineering. Yield improvement and process optimization. Root cause analysis and problem solving. New product introduction (NPI). Medical device manufacturing processes. Data analysis and process capability improvement. Cross-functional collaboration. Project management and leadership. Regulatory compliance (FDA, ISO 13485, GMP).

Qualification And Education:

Bachelor s degree in Mechanical, Chemical, Biomedical, or related engineering field required or equivalent experience.