Senior Process Development Engineer

Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

The Sr PD Engineer will be a key member of the manufacturing development and support team partnering with management, Quality Assurance, R&D / Product Development, and Production functions. This is a multi-faceted role with the Engineer responsible for assisting in several critical areas including :

• Test method development and validation
• Process and product characterization
• Equipment validation & calibration set-up and requirements
• Conducting feasibility studies and pilot programs for new process technologies.
• Identifying and implementing new technologies and methodologies to improve existing processes

The person shall execute duties to meet cGMP requirements on time and to the highest quality standards to ensure that programs are compliant with regulatory requirements and related site SOPs. This role will have a heavy emphasis on biological tissue, production, performance, and characterization.

Primary Duties and Responsibilities

1. Process Development and Optimization :

2. Jig Fixture Automation :

3. Validation and Documentation :

4. GMP Compliance :

5. Cross-Functional Collaboration :

Skills, Knowledge, Experience & Qualifications

What We Offer :

Health and Wellness Offerings :

Note : We may require proof of COVID-19 vaccination to comply with the 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, multiculturism 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.