STAFF MANUFACTURING & PROCESS DEVELOPMENT ENGINEER- Electrophysiology Catheter NPD

TE Connectivity Ltd.; Plymouth (MN); Sur place; USD 125 000 - 187 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k)

Résumé du poste

TE Connectivity is seeking a Staff Manufacturing & Process Development Engineer for Electrophysiology catheter NPD in Plymouth, MN. You will lead manufacturing transfer, DFx improvements, and process validation efforts to ensure scalable, compliant production.

Responsibilities include SME leadership, process platform development, advanced characterization, and cross-functional collaboration with R&D and Automation to deliver robust catheter manufacturing solutions.

Qualifications

• BS degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or related technical discipline.
• Advanced degree (MS) preferred.
• Experience in medical device manufacturing or EP catheter programs is highly valued.

Responsabilités

• Serve as SME for EP catheter manufacturing processes.
• Design and establish standard manufacturing platforms for next-generation EP technologies.
• Lead process capability studies, DOE, and design for manufacturability improvements.
• Coordinate with R&D and Automation to implement DFMA for complex catheters.
• Lead IQ/OQ/PQ validation activities for catheter assembly and testing equipment.
• Drive defect prevention and correction through pFMEAs and robust process controls.
• Manage capital projects and equipment procurement for manufacturing improvements.
• Perform root-cause analysis on MRB items and non-conformances.

Formation

Bachelor's degree in Mechanical, Biomedical, Manufacturing Engineering, Materials Science, or related technical discipline

Outils

Minitab

Statistical methods

Description du poste

STAFF MANUFACTURING & PROCESS DEVELOPMENT ENGINEER- Electrophysiology Catheter NPD

Posting Start Date: 9/29/26

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 Description:

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

• 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 (https://www.linkedin.com/company/te-connectivity/) ,Facebook (https://www.facebook.com/teconnectivity/) ,WeChat, (http://www.te.com.cn/chn-zh/policies-agreements/wechat.html) Instagram andX (formerly Twitter). (https://twitter.com/TEConnectivity)

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

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 and its subsidiaries, affiliates, and operating units (collectively, the "Company") is committed to providing a work environment that prohibits discrimination on the basis of age, color, disability, ethnicity, marital status, national origin, race, religion, gender, gender identity, sexual orientation, protected veteran status, disability or any other characteristics protected by applicable law or regulation.