Senior Manufacturing Engineer

Role:

Sr.

Manufacturing Engineer Location:

Plymouth, MN Key Responsibilities:

Lead yield improvement and continuous improvement initiatives across manufacturing processes Troubleshoot and resolve process issues using DMAIC, RCA, and data-driven methodologies Support catheter manufacturing processes including assembly, bonding, soldering, reflow, stringing, and packaging Support NPI, process scale-up, and technology transfer activities Collaborate with Quality, R D, Operations, and Regulatory teams Ensure compliance with

FDA, ISO

13485, and GMP requirements Mentor junior engineers and support cross-functional project execution

Required Qualifications:

5+ years of manufacturing/process engineering experience Strong medical device manufacturing background Experience with catheter manufacturing processes preferred Knowledge of

FDA, ISO

13485, GMP, CAPA, and process validation