Job Overview

Relocation: No

Travel: Less than 10%

Education Experience: Bachelor’s Degree in Engineering or related technical field

Employment Experience: 2–5 years (or Master’s + 1–3 years) of medical device experience, with a focus on catheter development and manufacturing.

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

Job Overview

TE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD-driven new product development projects. We are seeking a Process Development Engineer II to support Electrophysiology (EP) catheter New Product Development (NPD) programs.

In this key technical role, you will contribute to the bridge between Product Development and Manufacturing Engineering, helping execute the transfer of complex EP catheter designs into robust, scalable manufacturing operations. Located in Plymouth, MN, you will apply Design for Manufacturability (DFM) principles, support the development and execution of core manufacturing processes (such as braiding, reflow, sensor integration, micro-assembly, and electrical cable integration and termination), and execute process characterization and validation efforts to meet strict regulatory and quality standards.

Responsibilities

• Process Execution & Optimization: Support the development, optimization, and baseline establishment of core EP catheter manufacturing processes (e.g., polymer reflow, braiding, tipping, laser welding, micro-soldering, and electrical termination).
• Process Characterization: Execute process capability studies, screening evaluations, and standard Design of Experiments (DOE) under senior technical guidance to establish stable processing windows.
• Design for Manufacturability (DFM): Collaborate with R&D Product Development engineers to provide process feedback on multi-lumen shafts, handle assemblies, sensor/electrode integration, and tip sub-assemblies during early prototyping and pilot production.
• Automation Collaboration: Support Design for Manufacturability (DFMA) efforts for complex EP catheters in collaboration with senior engineers and the Automation Engineering team. Assist in defining user requirements (URS), evaluating fixtures/tooling, and executing integration trials for automated or semi-automated assembly platforms.
• Process Validation Execution: Draft, execute, and author reports for Equipment Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) for catheter assembly and test equipment.
• Defect Prevention & Quality Control: Assist in drafting pFMEAs, implementing in-process controls, and executing mistake-proofing (Poka-Yoke) solutions to maintain validated states and maximize yields.
• Tooling & Equipment: Assist with specifying, procuring, and qualifying new manufacturing fixtures, tooling, and baseline equipment required for new product lines.
• Root Cause Analysis: Participate in technical problem-solving for Material Review Board (MRB) items and Non-Conformance Reports (NCMRs), utilizing structured root-cause tools (e.g., 5-Why, Fishbone) to resolve manufacturing issues.
• Cross-Functional Collaboration: Partner effectively with Quality Engineering, Operations, R&D, and Technician staff to ensure smooth technology transfer to production lines.

Job Requirements

Qualifications

• Education: BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or a related technical discipline.
• Experience: 2–5 years of hands-on experience in medical device manufacturing or process development (or MS with 1–3 years). Experience with catheter manufacturing, steerable shafts, or micro-assembly is highly preferred.
• Technical Knowledge: Exposure to or foundational knowledge of catheter manufacturing techniques, such as reflow, braiding, thermal bonding, UV bonding, laser welding, micro-soldering, or sensor assembly.
• Statistical Application: Proficiency with statistical analysis tools (e.g., Minitab) for data analysis, capability studies (), hypothesis testing, and basic DOE applications.
• Validation Experience: Direct experience drafting or executing IQ/OQ/PQ protocols within an ISO 13485 / FDA QSR regulated environment.

Competencies