Senior Medical Device Process Engineer — Validation & Automation

Anteris Group; Brooklyn Park (MN); On-site; USD 120,000 - 135,000; Full time

Benefits offered by this job

Stock options

401k + Company Match

Medical/Dental/Vision

Job summary

Anteris Technologies seeks a Senior Process Development Engineer to join the Manufacturing Development and Support team. The role focuses on developing, validating, and optimizing manufacturing processes for Class III structural heart devices, with emphasis on tissue processing, automation, and regulatory compliance.

You will work with cross-functional teams to drive process improvements, execute validation protocols, and ensure scalable, compliant production, in a fast-paced, global environment.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Industrial Engineering, or related field.
• 5+ years of Process Development and Validation experience in the medical device industry.
• Experience with catheter or sheath manufacturing processes and validation activities.

Responsibilities

• Develop and optimize manufacturing processes for medical devices with focus on performance, quality, scalability and efficiency.
• Lead process characterization activities from OQ readiness to commercialization.
• Drive continuous improvement to enhance product quality and reduce manufacturing cost.
• Apply problem-solving methods (5 Whys, Fishbone) and statistical analysis to resolve issues.
• Lead risk management per ISO 14971 and FDA 21 CFR Part 820 across product lifecycle.
• Collaborate with R&D/QA/Production to ensure integration of new processes.

Skills

Process development

Validation

GMP compliance

ISO 13485

Cross-functional collaboration

Catheter manufacturing

Automation implementation

Root cause analysis

Education

Bachelor’s degree in Mechanical/Biomedical/Industrial Engineering or related field

Advanced degree preferred

Tools

Automation equipment

Jig fixture design

Statistical analysis software

Job description

Anteris Technologies seeks a Senior Process Development Engineer to join the Manufacturing Development and Support team. The role focuses on developing, validating, and optimizing manufacturing processes for Class III structural heart devices, with emphasis on tissue processing, automation, and regulatory compliance.

You will work with cross-functional teams to drive process improvements, execute validation protocols, and ensure scalable, compliant production, in a fast-paced, global environment.