MANUFACTURING & PROCESS DEVELOPMENT ENGINEER- Electrophysiology Catheter NPD

TE Connectivity; Plymouth (MN); Sur place; USD 82 000 - 103 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k)

Résumé du poste

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.

Located in Plymouth, MN, you will help transfer complex EP catheter designs into robust manufacturing operations, applying DFM principles and supporting core processes like braiding, reflow, sensor integration, and electrical

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 preferred.
• Technical knowledge: catheter manufacturing techniques such as reflow, braiding, thermal bonding, UV bonding, laser welding, micro-soldering, sensor assembly.
• Statistical applications: proficiency with statistical analysis tools (e.g., Minitab) for capability studies and basic DOE.
• Validation experience: drafting/executing IQ/OQ/PQ protocols in ISO 13485 / FDA QSR environments.

Responsabilités

• Support development, optimization, and baseline establishment of core EP catheter manufacturing processes.
• Execute process capability studies, DOE, and screening evaluations.
• Provide process feedback on multi-lumen shafts, handle assemblies, and sensor integration during prototyping.
• Assist DFMA efforts for complex EP catheters and evaluate fixtures/tooling for automation.
• Draft and execute IQ/OQ/PQ reports for catheter assembly and test equipment.
• Draft in-process controls and Poka-Yoke solutions to maximize yields.
• Assist with selecting and qualifying new fixtures, tooling, and baseline equipment.
• Participate in root-cause analysis for MRB and NCMR items using 5-Why/Fishbone.

Connaissances

Statistical analysis

Process development

DOE

Formation

BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or related technical discipline

Outils

Minitab

IQ/OQ/PQ protocols

Description du poste

MANUFACTURING & PROCESS DEVELOPMENT ENGINEER- Electrophysiology Catheter NPD Job Description Job Alerts Link Job Title: 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.

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

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

Job Locations:

5905 TRENTON LN N
PLYMOUTH, Minnesota 55442
United States