STAFF MFG & PROCESS DVL ENGINEER- Electrophysiology Catheter NPD

TE Connectivity Ltd.; Plymouth (MN); On-site; USD 125,000 - 187,000; 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 is seeking a Staff Mfg & Process Dvl Engineer focused on Electrophysiology catheter NPD in Plymouth, MN. You will lead EP catheter transfer to manufacturing, optimize design for manufacturability, and drive process platforms and validation to meet regulatory standards.

The role requires 8+ years in medical device manufacturing with EP catheter experience, and a BS with an MS preferred. Expect cross-site collaboration and ownership of capital projects and automation integration.

Qualifications

• BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or related field; MS preferred.
• 8+ years of medical device manufacturing/process development experience with EP catheter focus.
• Expert knowledge of catheter manufacturing methods: polymer reflow, braiding, tipping, laser welding, micro-soldering, electrical termination, sensor/electrode assembly.
• Strong statistical analysis skills using Minitab; experience with ANOVA, regression, DOE.
• Experience bringing medical devices from concept through validation to production.
• Excellent cross-functional communication and customer-facing skills.

Responsibilities

• Serve as SME for EP catheter manufacturing processes and guide cross-functional teams.
• Design, develop, and establish standard manufacturing platforms for next-gen EP technologies.
• Lead complex process capability studies using DOE to establish robust operating windows.
• Collaborate with R&D to optimize complex multi-lumen shaft configurations and sensor integration.
• Drive DFMA for EP catheters with Automation team to specify equipment and integrate automated platforms.
• Lead IQ/OQ/PQ validation of catheter assembly and testing equipment.
• Implement pFMEAs and advanced process controls to prevent failures and sustain validated states.
• Manage capital projects from justification to procurement and automation implementation.
• Lead root-cause analysis for MRB items and NCMRs.

Skills

EP catheter manufacturing

Process development leadership

DFM/DFMA

Statistical analysis

DOE design of experiments

Cross-functional collaboration

Regulatory compliance

Education

BS in Mechanical/Biomedical/Manufacturing Eng or Materials Science

MS degree preferred

Tools

Minitab

ANOVA/Regression

Job description

STAFF MFG & PROCESS DVL ENGINEER- Electrophysiology Catheter NPD Job Description Job Alerts Link 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.

Job Overview

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.

Job Overview

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.

Responsibilities

• 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.

Job Requirements

Qualifications

• Education: BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or a related technical discipline. An advanced degree (MS) is highly preferred.
• Experience: 8+ years of hands-on experience in medical device manufacturing/process development. A minimum of 4–5 years dedicated specifically to Electrophysiology (EP) catheter manufacturing or highly complex steerable catheter programs is required.
• Technical Expertise: In-depth knowledge of specialized catheter manufacturing methods, including polymer reflow, braiding, tipping, laser welding, micro-soldering, electrical termination, and sensor/electrode assembly.
• Statistical Proficiency: Expert-level capability in statistical analysis software (e.g., Minitab), utilizing ANOVA, regression, and advanced DOE techniques to drive process optimization.
• Execution: Proven track record of successfully bringing medical devices from concept through formal validation (V&V) and into commercial production.
• Customer Focused: Customer facing communications. Experience relaying root cause analysis results and process details to internal and external customers. Ability to listen to a customer and convert that into specifications.
• Communication: Exceptional analytical, problem-solving, and cross-functional communication skills.
• Team Focused: Ability to coordinate and work across sites, as this engineer may well be working with engineers in other facilities or handing off processes to production.

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: $124,700 – 187,000 (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.

Job Locations

5905 TRENTON LN N
PLYMOUTH, Minnesota 55442
United States

Posting City: PLYMOUTH Job Country: United States Travel Required: 10% to 25% Requisition ID: 152332 Workplace Type: Onsite External Careers Page: Engineering & Technology

TE Connectivity does not accept unsolicited assistance from third parties for employment opportunities. All CVs/resumes submitted to any TE employee by a third party without a valid written search agreement for that specific position will not be entitled to any form of compensation and such submission shall be deemed the sole property of TE. No fee will be paid in the event an individual is hired by TE regardless of any third party submission where no pre-existing written search agreement is in place. If an agency agreement is in place, submissions are position specific. General submissions not targeted at a specific employment opportunity will not be entitled to any form of compensation. Please, no phone calls or emails. © 2023 TE Connectivity Corporation. All Rights Reserved.