Manufacturing & Process Development Engineer- Electrophysiology Catheter NPD

MANUFACTURING & PROCESS DEVELOPMENT ENGINEER- Electrophysiology Catheter NPD

MANUFACTURING & PROCESS DEVELOPMENT 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.
Bachelor’s Degree in Engineering or related technical field
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.
TE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD-driven new product development projects. We are seeking a 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 , 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.
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).
Execute process capability studies, screening evaluations, and standard Design of Experiments (DOE) under senior technical guidance to establish stable processing windows.
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.
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.
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.
Assist with specifying, procuring, and qualifying new manufacturing fixtures, tooling, and baseline equipment required for new product lines.
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.
Partner effectively with Quality Engineering, Operations, R&D, and Technician staff to ensure smooth technology transfer to production lines.

BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or a related technical discipline.
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.
Exposure to or foundational knowledge of catheter manufacturing techniques, such as reflow, braiding, thermal bonding, UV bonding, laser welding, micro-soldering, or sensor assembly.
Proficiency with statistical analysis tools (e.g., Minitab) for data analysis, capability studies (), hypothesis testing, and basic DOE applications.
Direct experience drafting or executing IQ/OQ/PQ protocols within an ISO 13485 / FDA QSR regulated environment.

Values: Integrity, Accountability, Inclusion, Innovation, Teamwork
TE Connectivity plc (NYSE: TEL) is a global industrial technology leader creating a safer, sustainable, productive, and connected future. As a trusted innovation partner, our broad range of connectivity and sensor solutions enable the distribution of power, signal and data to advance next-generation transportation, energy networks, automated factories, data centers enabling artificial intelligence, and more.
Our more than 90,000 employees, including 10,000 engineers, work alongside customers in approximately 130 countries. In a world that is racing ahead, TE ensures that EVERY CONNECTION COUNTS. Learn more at and on , , and
Competitive base salary commensurate with experience: $82,000 – 102,500 (subject to change dependent on physical location) Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity. Total Compensation = Base Salary + Incentive(s) + Benefits
A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.
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