Senior EP Catheter Process Engineer - NPD Lead

TE Connectivity; Plymouth (MN); On-site; USD 125,000 - 187,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Disability insurance

Life insurance

Employee stock purchase plan

Paid time off

Job summary

TE Connectivity seeks a Staff Process Development Engineer to lead EP catheter NPD programs in Plymouth, MN. You will bridge Product Development and Manufacturing, optimize manufacturability, and drive new process platforms like braiding and sensor integration.

The role emphasizes process characterization, validation, and cross-functional leadership to deliver scalable manufacturing aligned with strict regulatory and quality standards.

Qualifications

• BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or related field; MS preferred.
• 8+ years hands-on medical device manufacturing; 4–5 years EP catheter manufacturing experience required.
• Expert knowledge of EP catheter manufacturing methods: polymer reflow, braiding, tipping, laser welding, micro-soldering, electrical termination, sensor assembly.
• Proficient in statistical analysis software (Minitab) with ANOVA, regression, and advanced DOE techniques.
• Track record of bringing medical devices from concept through V&V to production.

Responsibilities

• Technical Leadership: SME for EP catheter manufacturing, guide cross-functional teams.
• Process Platform Development: create standard platforms for next-gen EP technologies.
• Advanced Process Characterization: conduct studies to establish robust operating windows.
• Design for Manufacturability: optimize multi-lumen shaft, handle, electrical and sensor assemblies.
• Automation Integration: develop DFMA with automation team and integrate assembly platforms.
• Validation Excellence: author IQ/OQ/PQ for catheter assembly and testing equipment.
• Defect Prevention & Control: implement pFMEAs and mistake-proofing to sustain validated states.
• Capital Management: manage capital projects, procurements, and specifications.
• Root Cause Analysis: lead MRB/NCMR resolution with rigorous analysis.

Skills

EP catheter manufacturing

Process development

DFM/DFMA

DOE

Statistical analysis (Minitab)

Cross-functional collaboration

Quality/regulatory

Education

BS in Mechanical Engineering

BS in Biomedical/Manufacturing Engineering

MS preferred

Tools

Minitab

Job description

TE Connectivity seeks a Staff Process Development Engineer to lead EP catheter NPD programs in Plymouth, MN. You will bridge Product Development and Manufacturing, optimize manufacturability, and drive new process platforms like braiding and sensor integration.

The role emphasizes process characterization, validation, and cross-functional leadership to deliver scalable manufacturing aligned with strict regulatory and quality standards.