We are seeking an experienced Research and Development Engineer with deep medical device development expertise to participate in design activities across multiple structural heart programs. This role requires strong technical design capability and independence to advance a novel heart valve repair system from concept through commercialization. The successful candidate will collaborate effectively across engineering, clinical, regulatory, and executive teams while driving innovative solutions in the structural heart space. If you are an experienced R&D engineer with a passion for driving innovative solutions in the structural heart space, please submit your resume.

At Anteris Technologies, you’ll join a mission-driven team dedicated to improving the lives of patients with aortic stenosis through breakthrough structural heart technologies — and help build the organizational foundation supporting that impact.

Primary Responsibilities

• Characterize device-tissue interactions through the analysis of clinical/pre-clinical imaging datasets and benchtop data using both commercial and internally developed software packages.
• Lead R&D efforts in understanding the anatomical and physiological landscape a TAVR system interacts with through implantation and the product life cycle.
• Support the design and development of a TAVR system through innovative, agile and objective design processes.
• Develop comprehensive TAVR system test plans by defining clinically relevant boundary conditions and test parameters that support design verification and comply with applicable FDA, ISO, and other regulatory requirements.
• Collaborate with cross-functional partners across R&D, Clinical, and Regulatory to align project objectives with design improvements and clinical outcome goals.
• Utilize SolidWorks and other engineering tools to design and develop prototypes, and components for TAVR device design and development.
• 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.

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 Skills and Knowledge:

• Experience using DICOM analysis software such as Materialise Mimics or 3D Slicer.
• Strong understanding of cardiovascular anatomy and physiology.
• Experience designing and developing mechanical assemblies, preferably related to Class III medical devices.
• Competency in 3D modeling software, i.e. SolidWorks and/or Creo.
• Strong understanding of engineering principles/methodologies and relevant standards/directives, specifically ISO 5840.
• Experience using statistical analysis software to analyse and prepare test data for regulatory review (e.g. Minitab, JMP).
• Experience creating technical, written content.
• 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 Skills:

• Previous experience with catheter-based structural heart medical devices and interventional cardiology procedures.
• Experience with Design Verification planning, testing, and reports.
• Experience supporting pre-clinical testing and simulation studies
• Familiarity with human factors and systems engineering principles.
• Experience with risk management methodologies in the context of medical device testing.
• Experience with component qualifications, including using external manufacturers to build custom fixtures/components.
• Strong knowledge of Geometric Dimensioning and Tolerancing (GD&T) principles.
• Knowledge of applicable standards including ISO 5840, ISO 13485, ISO 14971, ISO 10555, and ISO 10993.

Compensation

Target base salary range: $116,000 - $136,000, 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 Offerings
• Healthcare & Flexible Spending Account (HSA / 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