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.

Primary Duties and 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.

Skills, Knowledge, Experience & Qualifications

Required Degree and Experience:

One of the following: 

• 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. 

Required Qualifications:

• 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.

Preferred Qualifications:

• 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.

Compensation:

Target base salary range: $120,000 – $140,000, plus eligibility for an annual short-term incentive (STI) targeted at 8.5% of base salary and equity participation. Final compensation will be determined based on experience and alignment with role requirements. Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

What We Offer:

• Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
• Collaborative and dynamic work environment with a culture of innovation and excellence.
• 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.

Health and Wellness Offerings:

• Medical, Dental, and Vision Plans
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Equity Program
• Paid Holidays & Vacation
• Employee Assistance Program
• Inclusive Team Environment