EP Catheter Process Engineer — Scale Manufacturing

TE Connectivity; Plymouth (MN); Presencial; USD 82.000 - 103.000; 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 in Plymouth, MN seeks a Process Development Engineer II to support EP catheter New Product Development programs. You will help transfer complex catheter designs into robust manufacturing, applying DFM principles and contributing to core processes such as braiding, reflow, and micro-assembly.

Join a cross-functional team, work under ISO 13485/FDA QSR regimes, perform process validation, CAPA, and continuous improvement to deliver high-quality medical devices while advancing

Formación

• Education: BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or a related technical discipline.
• Experience: 2–5 years in medical device manufacturing or process development; catheter manufacturing experience preferred.
• Technical Knowledge: Catheter manufacturing techniques such as reflow, braiding, thermal/UV bonding, laser welding, micro-soldering.
• Statistical Application: Proficiency with statistical analysis tools (eg, Minitab) for capability studies and data analysis.
• Validation Experience: Experience drafting or executing IQ/OQ/PQ protocols in ISO 13485 / FDA QSR environment.

Responsabilidades

• Process Execution & Optimization: develop, optimize, and baseline core EP catheter manufacturing processes.
• Process Characterization: perform capability studies and DOE to establish stable windows.
• DFM collaboration: work with R&D to feedback on multi-lumen shafts and assemblies.
• Automation Collaboration: support DFMA efforts and define URS for automation.
• Process Validation Execution: draft and execute IQ/OQ/PQ for catheter assembly equipment.
• Defect Prevention & Quality Control: implement in-process controls and Poka-Yoke solutions.
• Tooling & Equipment: specify and qualify new fixtures and baseline equipment for new lines.
• Root Cause Analysis: participate in solving MRB/NCMR issues using structured methods.
• Cross-Functional Collaboration: partner with Quality, Operations, R&D, and technicians for tech transfer.

Conocimientos

Process development

Statistical analysis

Problem solving

Educación

BS in Mechanical Engineering

Biomedical/Manufacturing Engineering or related

Herramientas

Minitab

Descripción del empleo

TE Connectivity in Plymouth, MN seeks a Process Development Engineer II to support EP catheter New Product Development programs. You will help transfer complex catheter designs into robust manufacturing, applying DFM principles and contributing to core processes such as braiding, reflow, and micro-assembly.

Join a cross-functional team, work under ISO 13485/FDA QSR regimes, perform process validation, CAPA, and continuous improvement to deliver high-quality medical devices while advancing