Manufacturing & Process Developm Entengineer- Electrophysiology Catheter NPD

Manufacturing & Process Development Engineer
- Electrophysiology Catheter NPD

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.

Compensation:

Competitive base salary commensurate with experience: $82,000 – 102,500 (subject to change dependent on physical location)

Total Compensation = Base Salary + Incentive(s) + Benefits

Benefits:

• A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

Job Location s: 5905 TRENTON LN N PLYMOUTH, Minnesota 55442 United States Posting City: PLYMOUTH Job Country:
United States

Travel Required:

10% to 25% Requisition  Workplace Type:
Onsite