STAFF MANUFACTURING & PROCESS DEVELOPMENT ENGINEER- Electrophysiology Catheter NPD

TE Connectivity; 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

Voluntary benefits

Job summary

TE Connectivity is seeking a Staff Process Development Engineer to lead EP catheter NPD programs and transfer designs into scalable manufacturing operations.

You will optimize manufacturability, develop new process platforms, and drive validation efforts to meet strict quality standards across global facilities.

Qualifications

• BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or related discipline. An advanced degree (MS) is highly preferred.
• 8+ years of hands-on experience in medical device manufacturing/process development. 4–5 years in EP catheter manufacturing or complex steerable catheter programs.
• In-depth knowledge of catheter manufacturing methods including polymer reflow, braiding, tipping, laser welding, micro-soldering, electrical termination, sensor/electrode assembly.
• Expert-level capability in statistical analysis software (e.g., Minitab), ANOVA, regression, and advanced DOE techniques.
• Proven track record bringing medical devices from concept through V&V into production.

Responsibilities

• SME for EP catheter manufacturing processes, guiding cross-functional teams.
• Design, develop, and establish standard manufacturing platforms for next-gen EP technologies.
• Lead process characterization studies using DOE and advanced statistics.
• Optimize DFM with R&D Product Development; prototype tooling.
• Author and execute IQ, OQ, PQ for catheter assembly and testing equipment.
• Implement advanced process controls and pFMEA to prevent defects.
• Manage high-visibility capital projects from justification to automation deployment.
• Lead root-cause analysis for MRB items and NCMRs.

Skills

EP catheter manufacturing

Design of Experiments

Statistical analysis (Minitab)

Process development

Education

BS in Mechanical/Biomedical/Manufacturing Engineering or Materials Science

MS preferred

Tools

Minitab

Laser welding equipment

Braiding/ tip tooling equipment

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

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. You will lead the optimization of designs for manufacturability (DFM), pioneer new process platforms (such as braiding, reflow, sensor integration, micro-assembly, and electrical 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 tip assembly integration, and realize early-stage prototyping and sample tooling.
• 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.

Qualifications

Job Requirements

• 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 that is comfortable relaying root cause analysis results, process details someone who can 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.

EOE, Including Disability/Vets