Senior Test Engineer

Anteris Technologies•Brooklyn Park, MN

12d•$120,000 - $140,000

About The Position

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 SolidWorks 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.

Requirements

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. SolidWorks and/or ProEngineer.
Ability to interpret technical drawings and create a Bill of Materials.
Experience using statistical analysis software to analyze and prepare test data for regulatory review (e.g. Minitab, JMP).
Experience creating technical, written content.
Strong knowledge of Geometric Dimensioning and Tolerancing (GD&T) principles.
Experience with component qualifications, including using external manufacturers to build custom fixtures/components.
Excellent problem-solving skills and the ability to think critically in complex engineering scenarios.
Communication, presentation, technical writing, and organizational skills.
Ability to manage multiple tasks and projects and to work independently as well as contribute to a team environment.
Working knowledge of Microsoft Office tools.

Nice To Haves

Experience in product design and development in an R&D environment.
Previous experience with catheter-based medical devices and interventional cardiology procedures.
Experience supporting pre-clinical testing and simulation studies.
Experience with risk management methodologies in the context of medical device testing.

Responsibilities

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 SolidWorks 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.