EP Catheter Manufacturing & Process Engineer

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

Benefits offered by this job

Health insurance

401(k) plan

Disability insurance

Life insurance

Employee stock purchase plan

Paid time off

Voluntary benefits

Job summary

TE Connectivity in Plymouth, Minnesota, seeks an R&D Process Development Engineer II focused on electrophysiology catheter technologies, bridging concept to manufacturing.

You will develop and scale manufacturing platforms, apply DOE, and ensure DFМ/ISO compliance with regulatory standards. Collaboration across LEANPD and product development drives high-quality, manufacturable solutions.

Qualifications

• Bachelor’s degree in a mechanical, manufacturing, biomedical, materials science or related technical field.
• 3–5 years of professional experience in medical device process development or R&D.
• Strong background in statistical analysis (Minitab or JMP preferred), root cause analysis, and proficiency in English.
• Ability to coordinate across sites or hand off processes to production.

Responsibilities

• Develop and optimize manufacturing platforms for EP catheters, including electrode bonding, micro-assembly, catheter shaft lamination, and braiding.
• Design and develop specialized fixturing for repeatable component positioning to ensure manufacturing accuracy.
• Apply DOE and scientific methods to characterize process limits and resolve complex micro-scale assembly challenges.
• Lead IQ and OQ/PQ validations to meet FDA/ISO regulatory standards.
• Implement robust process controls and create detailed work instructions for cleanroom manufacturing.
• Identify equipment needs for new programs; justify automation and assembly hardware.
• Lead root cause investigations and MRB/NCMR actions with long-term corrective actions.
• Provide cross-functional guidance to product development for optimized assembly, cost, and quality.

Skills

Statistical analysis

Root cause analysis

English proficiency

Education

Bachelor’s degree in Mechanical, Manufacturing, Biomedical Engineering, Materials Science or related field

Job description

TE Connectivity in Plymouth, Minnesota, seeks an R&D Process Development Engineer II focused on electrophysiology catheter technologies, bridging concept to manufacturing.

You will develop and scale manufacturing platforms, apply DOE, and ensure DFМ/ISO compliance with regulatory standards. Collaboration across LEANPD and product development drives high-quality, manufacturable solutions.