PLYMOUTH STAFF MANUFACTURING & PROCESS DEVELOPMENT ENGINEER Electrophysiology Catheter NPD MN 55442

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.

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 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