Sr. Manufacturing Engineer

Sr. Manufacturing Engineer at ProKatchers LLC Sr. Manufacturing Engineer at ProKatchers LLC in Minneapolis, Minnesota Posted in 2 days ago.

Type:

full-time

Job Description:

Job Title :

Sr.

Manufacturing Engineer Location :

Plymouth, MN 55442

Duration :

06 months

Job Description:

Manufacturing & Yield Improvement Lead yield improvement initiatives across catheter manufacturing processes, including reflow, stringing, assembly, soldering, bonding, and packaging. Apply structured problem-solving methodologies (e.g., DMAIC, Root Cause Analysis, A3) to resolve manufacturing issues and improve process capability and robustness. Analyze manufacturing data to identify trends, process variation, and opportunities for cost, quality, and throughput improvements. Technical Leadership & Execution Serve as a technical subject matter expert in catheter manufacturing processes, materials, and equipment. Coordinate the design, procurement, build, and debugging of tooling, machinery, and test equipment. Support new product introductions (NPI), process scale up, and technology transfer from R D to manufacturing. Work collaboratively with Quality, Process Development, R D, Supply Chain, Operations, and Regulatory teams to ensure successful launches and sustained performance. Ensure manufacturing processes comply with

FDA, ISO

13485, GMP, and Abbott quality system requirements. Provide technical guidance during investigations, process development, and continuous improvement activities. Required Qualifications Bachelor's degree in Mechanical, Chemical, Biomedical, or other relevant engineering discipline, or equivalent technical experience. Minimum 5 years of manufacturing engineering experience, with background in manufacturing or process development. Preferred Qualifications Medical device manufacturing experience (required). Previous experience supporting NPI, pilot builds, and ramp to production environments.