MFG & Process DVL Engineer- Electrophysiology Catheter NPD

STAFF MFG & PROCESS DVL ENGINEER
- Electrophysiology Catheter NPD

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Job Title:

STAFF MFG & PROCESS DVL ENGINEER
- Electrophysiology Catheter NPD

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Relocation: No

Travel: Less than 10%

Education

Experience:

Bachelor’s Degree in Engineering or related technical field

Employment

Experience:

8+ years (or Master’s + 5 years) of medical device experience, with a heavy focus on complex catheter technologies.

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

TE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD-driven new product development projects. We are seeking a Staff Process Development Engineer to serve as the technical lead for Electrophysiology (EP) catheter New Product Development (NPD) programs.

In this high-impact role, you will act as the principal binding element between Product Development and Manufacturing Engineering, ensuring the seamless transfer of complex EP catheter designs into robust, scalable manufacturing operations. Located in Plymouth, MN
, you will lead the optimization of designs for manufacturability (DFM), pioneer new process platforms (such as braiding, reflow, sensor integration, micro-assembly, and electrical cable integration and termination), and spearhead process characterization and validation efforts to meet strict regulatory and quality standards.

• Technical Leadership: Serve as the subject matter expert (SME) for EP catheter manufacturing processes, providing strategic technical and professional guidance to cross-functional teams, junior engineers, and technicians.
• Process Platform Development: Design, develop, and establish standard manufacturing platforms for next-generation EP technologies (e.g., mapping, ablation, and steerable sheaths).
• Advanced Process Characterization: Lead complex process capability and characterization studies using advanced statistical methods and Design of Experiments (DOE) to establish robust operating windows.
• Design for Manufacturability (DFM): Partner closely with R&D Product Development to optimize complex multi-lumen shaft configurations, handle assembly, electrical cable assembly and sensor integration, and tip assembly integration from early-stage prototyping.
• Automation Integration: Drive Design for Manufacturability (DFMA) for complex EP catheters - working in close collaboration with the Automation Engineering team to co-develop equipment specs (URS), evaluate custom machine concepts, and seamlessly integrate automated assembly platforms into production.
• Validation Excellence: Author and execute comprehensive Equipment Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) for specialized catheter assembly and testing equipment.
• Defect Prevention & Control: Implement advanced process controls, pFMEAs, and mistake-proofing methodologies to prevent process failures and sustain validated states.
• Capital Management: Manage high-visibility capital improvement projects, including equipment justification, drafting precise specifications, procurement, and automation implementation.
• Root Cause Analysis: Lead the technical resolution of material review board (MRB) items and non-conformance reports (NCMRs) by applying rigorous root-cause analysis tools to resolve deep technical manufacturing challenges.

• Education: BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science,…