MANUFACTURING & PROCESS DEVELOPM ENTENGINEER- Electrophysiology Catheter NPD
TE Connectivity · PLYMOUTH, MN, US, 55442 · United States · On-site
Pay: USD 82,000 – 102,500 a year
Sign up free: we match you to jobs like this, tailor your application and fill the form. 2 free applications every day.
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
Job Overview
At TE Connectivity, we create the connections that power the future of healthcare. As an R&D Process Development Engineer II, you will play a pivotal role in our Medical business unit, specifically focusing on the design and manufacture of high-precision Electrophysiology (EP) catheter technologies. You will act as the vital link between initial product concept and full-scale manufacturing. Your mission is to ensure that next-generation EP catheters—complex devices involving intricate sensors, electrodes, and steerable shafts—are designed for manufacturability (DFM) and produced using stable, high-yield processes. You will work within our LEANPD framework to develop, qualify, and scale the manufacturing technologies that make life-saving cardiac procedures possible.
Core Responsibilities • Process Innovation & Design: Develop and optimize manufacturing platforms specifically for EP catheters, including electrode bonding, micro-assembly, catheter shaft lamination, and braiding. • Fixture Development: Designs and develops specialized fixturing that secures components in the exact same position repeatability ensuring manufacturing operations without errors. • Technical Problem Solving: Apply scientific principles and DOE (Design of Experiments) to characterize process limits and resolve complex technical challenges inherent in micro-scale medical device assembly. • Validation & Compliance: Lead the execution of Equipment Installation Qualifications (IQ) and Process Validations (OQ/PQ) to ensure all methods meet stringent FDA/ISO regulatory standards. • Productivity & Control: Implement robust process controls and visual management to prevent failures. Prepare detailed work instructions and technical documentation for cleanroom manufacturing. • Capital Management: Identify equipment needs for new programs; manage the specification, procurement, and justification of advanced automation and assembly hardware. • Root Cause Analysis: Lead investigations into non-conformances (NCMR) and Material Review Board (MRB) items, identifying root causes and implementing long-term corrective actions. • Cross-Functional Collaboration: Provide technical guidance to Product Development to ensure designs are optimized for assembly, cost-efficiency, and high quality.
Job Requirements
Required Qualifications: • Education: Bachelor’s Degree in Mechanical, Manufacturing, or Biomedical Engineering, Material Science, or a related technical field. • Experience: 3–5 years of professional experience in medical device process development or R&D. • Technical Expertise: Strong background in statistical analysis (Minitab or JMP preferred), root cause analysis, and proficiency in English. • Team Focused: Ability to coordinate and work across sites, as this…