Senior Process Engineer, Medical Devices & Automation

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

Benefits offered by this job

Medical, Dental, Vision plans

401k + Company Match

Stock options

Paid holidays & vacation

Employee Assistance Program

Job summary

Anteris Technologies in Minneapolis, MN, is seeking a Senior Process Development Engineer to advance manufacturing methods for Class III heart devices. You will drive process characterization, validation, and continuous improvement across R&D, QA, and Production.

The role emphasizes tissue-based device manufacturing, automation, documentation, and compliance with GMP/ISO 13485, with collaboration across cross-functional teams to scale technologies for production.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Industrial Engineering or related field.
• 5+ years in process development and validation within the medical device industry.
• Experience with catheter or sheath manufacturing processes.
• Strong knowledge of GMP, ISO 13485, FDA QSR and validation documentation practices.
• Excellent analytical, troubleshooting, and communication skills.

Responsibilities

• Develop and optimize manufacturing processes for medical devices with focus on performance and scalability.
• Lead process characterization activities and transition processes through OQ readiness and commercialization.
• Drive cost reduction, quality improvements, and throughput increases.
• Apply structured problem-solving and risk management to ensure compliant processes.
• Lead validation activities (IQ, IMV/TMV, OQ, PQ) and document results.
• Support technology transfer and scale-up to production across functions.

Skills

Process development

Validation

GMP/ISO 13485

Problem solving

Cross-functional collaboration

Education

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

Job description

Anteris Technologies in Minneapolis, MN, is seeking a Senior Process Development Engineer to advance manufacturing methods for Class III heart devices. You will drive process characterization, validation, and continuous improvement across R&D, QA, and Production.

The role emphasizes tissue-based device manufacturing, automation, documentation, and compliance with GMP/ISO 13485, with collaboration across cross-functional teams to scale technologies for production.