Development Engineering Tech I

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting‑edge valve, incorporating our proprietary ADAPT® anti‑calcification technology, is designed to mimic the natural function of a healthy heart valve.

Anteris is seeking a Process Development Engineer II to join our dynamic team in Brooklyn Park, MN. As a PD Engineer, you will play a vital role in the development and improvement of our medical devices' manufacturing processes. The ideal candidate should possess a Bachelor's degree and have a minimum of 2 years of experience working with Class II or Class III medical devices. Help us build a team that will shape the future of TAVR.

Develop and optimize manufacturing processes for medical devices, focusing on performance, quality, efficiency, and compliance with regulatory standards.

Create and implement manufacturing process IMV (Inspection Method Validation), TMV (Test Method Validation), IQ (Installation Qualification), OQ (Operational Qualification), and PPQ (Process Performance Qualification) activities.

Drive continuous improvement initiatives to enhance product quality, reduce manufacturing costs, and increase productivity through data analysis, root cause analysis, and the implementation of corrective actions.

Collaborate with cross‑functional teams, including R&D, Quality, and Manufacturing, to ensure seamless integration of new processes into production.

Oversee the implementation of automated processes, ensuring compliance with safety standards and regulatory requirements.

Prepare and execute validation protocols, including developing testing procedures, data analysis, and generating validation reports.

Conduct risk assessments and contribute to risk management activities related to the manufacturing process.

Create and maintain comprehensive documentation, such as work instructions, standard operating procedures (SOPs), and process flowcharts, in accordance with regulatory guidelines and Good Manufacturing Practices (GMP).

Ensure all processes and manufacturing activities adhere to Good Manufacturing Practices (GMP) and other relevant regulatory requirements.

Collaborate with the Quality Assurance team to address any compliance issues and implement corrective actions.

Work closely with the R&D team to provide manufacturing inputs during product development, ensuring manufacturability and scalability of new designs.

Bachelor's degree in Engineering (Mechanical, Industrial, Biomedical, or related).

Minimum of 2 years of experience in Process Development and Manufacturing Engineering within the medical device industry.

Understanding of Good Manufacturing Practices (GMP) and other relevant regulatory requirements.

Excellent problem‑solving skills and the ability to apply engineering principles to improve processes and solve technical challenges.

Target base salary range: $92,000 – $112,000, plus eligibility for an annual short‑term incentive (STI) targeted at 7% of base salary and equity participation. Unfortunately, we are unable to sponsor work visas at this time.

Competitive compensation package, including salary, performance‑based bonuses, and stock options.

Career development opportunities and a chance to be part of a growing company that values its employees.

Medical, Dental, and Vision Plans

Flexible Spending Account (FSA)

Life, AD&D, Short‑Term and Long‑Term Disability Insurance

Bonus Plan Eligibility

Employee Equity Program

Paid Holidays & Vacation

Employee Assistance Program

Note: We may require proof of COVID‑19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturalism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment – it is part of our mission to deliver the best structural heart products on a global scale.

#