Senior Process Development Engineer — Catheter Devices

Anteris Technologies; Brooklyn Park (MN); On-site; USD 150,000 - 170,000; Full time

Benefits offered by this job

Medical, Dental and Vision plans

Flexible Spending Account (FSA)

401k + Company Match

Life, AD&D, Short/Long Disability

Bonus Plan Eligibility

Employee Equity Program

Paid Holidays & Vacation

Employee Assistance Program

Job summary

Anteris Technologies seeks a Principal Process Development Engineer to lead development, validation, and optimization of manufacturing processes for our transcatheter heart valve platform. You will partner with QA, R&D, and Manufacturing to scale processes from development to commercialization.

The role requires deep expertise in catheter-based device manufacturing, executing full validation lifecycles, and mentoring junior engineers to advance manufacturing readiness and performance.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Minimum 10 years in process development and validation within regulated medical device manufacturing.
• At least 5 years supporting Class II medical device development programs.
• Experience with catheter manufacturing processes and validation lifecycle (IQ/OQ/PQ).
• Strong technical writing and cross-functional collaboration skills.

Responsibilities

• Lead development, characterization, and optimization of manufacturing processes for Class III catheter-based medical devices.
• Translate design intent into scalable, robust processes for clinical and commercial production.
• Drive validation strategies including pFMEA, IQ, IMV/TMV, OQ, PQ/PPQ.
• Develop Master Validation Plans and validation documentation.
• Support transfer of processes from R&D to Manufacturing focusing on yield and reproducibility.
• Lead root-cause investigations and continuous improvement initiatives.
• Provide mentorship to junior engineers and contribute to best practices.

Skills

Process development

Validation

Catheter manufacturing

DOE

Statistical analysis

Lean Six Sigma

Technical writing

Cross-functional collaboration

Mentorship

Root cause analysis

Education

Bachelor’s degree in Engineering

Advanced degree (preferred)

Tools

Master Validation Plan

Jigs and fixtures design

Job description

Anteris Technologies seeks a Principal Process Development Engineer to lead development, validation, and optimization of manufacturing processes for our transcatheter heart valve platform. You will partner with QA, R&D, and Manufacturing to scale processes from development to commercialization.

The role requires deep expertise in catheter-based device manufacturing, executing full validation lifecycles, and mentoring junior engineers to advance manufacturing readiness and performance.