EP Catheter MFG & Process Engineer - NPD Lead

TE Connectivity Ltd.; Plymouth (MN); Presencial; USD 125.000 - 187.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k)

Disability insurance

Life insurance

Employee stock purchase plan

Paid time off

Descripción de la vacante

TE Connectivity is seeking a Staff Mfg & Process Dvl Engineer focused on Electrophysiology catheter NPD in Plymouth, MN. You will lead EP catheter transfer to manufacturing, optimize design for manufacturability, and drive process platforms and validation to meet regulatory standards.

The role requires 8+ years in medical device manufacturing with EP catheter experience, and a BS with an MS preferred. Expect cross-site collaboration and ownership of capital projects and automation integration.

Formación

• BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or related field; MS preferred.
• 8+ years of medical device manufacturing/process development experience with EP catheter focus.
• Expert knowledge of catheter manufacturing methods: polymer reflow, braiding, tipping, laser welding, micro-soldering, electrical termination, sensor/electrode assembly.
• Strong statistical analysis skills using Minitab; experience with ANOVA, regression, DOE.
• Experience bringing medical devices from concept through validation to production.
• Excellent cross-functional communication and customer-facing skills.

Responsabilidades

• Serve as SME for EP catheter manufacturing processes and guide cross-functional teams.
• Design, develop, and establish standard manufacturing platforms for next-gen EP technologies.
• Lead complex process capability studies using DOE to establish robust operating windows.
• Collaborate with R&D to optimize complex multi-lumen shaft configurations and sensor integration.
• Drive DFMA for EP catheters with Automation team to specify equipment and integrate automated platforms.
• Lead IQ/OQ/PQ validation of catheter assembly and testing equipment.
• Implement pFMEAs and advanced process controls to prevent failures and sustain validated states.
• Manage capital projects from justification to procurement and automation implementation.
• Lead root-cause analysis for MRB items and NCMRs.

Conocimientos

EP catheter manufacturing

Process development leadership

DFM/DFMA

Statistical analysis

DOE design of experiments

Cross-functional collaboration

Regulatory compliance

Educación

BS in Mechanical/Biomedical/Manufacturing Eng or Materials Science

MS degree preferred

Herramientas

Minitab

ANOVA/Regression

Descripción del empleo

TE Connectivity is seeking a Staff Mfg & Process Dvl Engineer focused on Electrophysiology catheter NPD in Plymouth, MN. You will lead EP catheter transfer to manufacturing, optimize design for manufacturability, and drive process platforms and validation to meet regulatory standards.

The role requires 8+ years in medical device manufacturing with EP catheter experience, and a BS with an MS preferred. Expect cross-site collaboration and ownership of capital projects and automation integration.