PLYMOUTH MANUFACTURING & PROCESS DEVELOPM ENTENGINEER Electrophysiology Catheter NPD MN 55442

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 engineer may well be working with engineers in other facilities or handing off processes to production. 

Preferred Experience:
•    Specialized Knowledge: Direct experience with Electrophysiology (EP) catheter technologies, including steerable handles, mapping electrodes, or ablation components.
•    Materials Insight: Understanding of medical-grade polymers, Pebax, nitinol, and precious metal electrode assemblies.
•    Soft Skills: A self-directed "hands-on" approach with a mindset for continuous improvement and innovation.

Competencies