Electrophysiology Catheter Process Development Engineer

TE Connectivity Ltd.; Plymouth (MN); On-site; USD 82,000 - 103,000; Full time

Benefits offered by this job

Health insurance

401(k)

Job summary

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.

Responsibilities

• 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.

Skills

Statistical analysis

Process development

DOE

Education

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

Tools

Minitab

IQ/OQ/PQ protocols

Job description

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