Senior Test Engineer

Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US;
Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

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. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. 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 dedicated to advancing medical technologies that improve patient outcomes and enhance the quality of life for individuals with cardiovascular conditions. We are seeking a highly skilled and experienced Senior Test Engineer with a strong background in TAVR devices to join our dynamic and growing team. As a Sr Test Engineer, you will play a crucial role in the development, testing, and validation of our TAVR devices.

Your expertise in Solid Works and Geometric Dimensioning and Tolerancing (GD&T) will be essential for designing and conducting both design verification and exploratory research test methods to assess TAVR performance, ensuring the highest standards of quality and compliance.

• Design, develop, and execute comprehensive test plans for our TAVR system including validation and verification testing and data analysis.
• Complete flow-based analysis of THV performance through hydrodynamic assessment and more complex test setups, such as particle image velocimetry or MR Imaging.
• Ensure all testing processes, documentation, and reports comply with relevant regulatory standards, including FDA and ISO requirements.
• Utilize Solid Works and other engineering tools to design and develop test fixtures, prototypes, and components for TAVR device testing and validation.
• Analyze test results, identify trends, and provide detailed reports to the engineering team and management for decision-making and refinement of the device design.
• Apply GD&T principles to accurately define and communicate the tolerances and dimensions of TAVR device components and assemblies for testing and manufacturing purposes.
• Work closely with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to ensure seamless integration of test processes throughout the product development lifecycle.
• Interface with vendors, manufacturing, and other internal groups and work with suppliers to ensure components meet design requirements & diagnose design problems.
• Continuously seek opportunities to optimize test methods, streamline processes, and improve overall efficiency to achieve project timelines and goals.
• Identify potential risks during the testing phase and collaborate with the team to implement appropriate mitigation strategies.
• Support and communicate decisions through thorough engineering practices and data analysis.
• Provide guidance and mentorship to junior engineers and team members, contributing to their professional development.

• PhD in Engineering, Physical Science or related discipline.
• Master's degree in Engineering, Physical Science, or related discipline with 2+ years of relevant experience.
• Bachelor's degree in Engineering, Physical Science, or related discipline with 4+ years of relevant experience.
• 8+ years experience in medical device product design and development.

• Experience designing, developing and executing benchtop test methods for Class III medical devices, preferably in the Structural Heart space.
• Strong understanding of design verification planning testing and reports.
• Strong understanding of relevant standards and directives, specifically ISO 5840.
• Competency in 3D modeling software, i.e. Solid Works and/or Pro…