MANUFACTURING & PROCESS DEVELOPMENT ENGINEER- Electrophysiology Catheter NPD

TE Connectivity; Plymouth (MN); On-site; USD 82,000 - 103,000; Full time

Benefits offered by this job

Health insurance

401(k)

Disability insurance

Life insurance

Employee stock purchase plan

Paid time off

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Process development

Statistical analysis

Problem solving

Education

BS in Mechanical Engineering

Biomedical/Manufacturing Engineering or related

Tools

Minitab

Job description

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

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.

Qualifications

Job Requirements

• 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 (
• Validation Experience: Direct experience drafting or executing IQ/OQ/PQ protocols within an ISO 13485 / FDA QSR regulated environment.

Competencies

Values: Integrity, Accountability, Inclusion, Innovation, Teamwork

ABOUT TE CONNECTIVITY

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 www.te.com and on LinkedIn, Facebook, WeChat, Instagram and X (formerly Twitter).

COMPENSATION

• 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

BENEFITS

• A comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

EOE, Including Disability/Vets