Principal R&D Engineer

Requirements

• Familiarity with manufacturing scale-up and process validation.
• Experience developing minimally invasive transcatheter heart valve repair or replacement devices.
• Familiarity with ca

Benefits

Additional Information

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. We are seeking an experienced Research and Development Engineer with deep medical device development expertise to serve as the technical Subject Matter Expert (SME) for catheter system design 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 design 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 Duties and Responsibilities Own technical decision-making for catheter architecture, materials, tolerances, and initial process development. Develop and execute design verification and validation strategies, including test method development and data analysis. Work collaboratively with cross-functional teams to drive product development from concept through commercialization while following documented design control processes, conducting risk management activities, and ensuring regulatory compliance. Evaluate design risks using tools such as FMEA, tolerance analysis, and failure investigations. Provide technical leadership in design reviews, risk assessments, and cross-functional forums. Partner closely with physicians and advisory board members to identify clinical and user needs and design innovative solutions. Lead definition of product design input requirements and translate them into mechanical designs, engineering documentation, and verification testing. Work closely with suppliers to ensure components meet design requirements, diagnose design issues, and collaborate to develop solutions. Present program progress, technical decisions, and development milestones to executives, external partners, and advisory board members. Drive continuous improvement of internal and external processes related to product development and manufacturability. Skills, Knowledge, Experience & Qualifications Required Qualifications: Bachelor's degree in Engineering required, ideally Mechanical or Biomedical; MS or PhD preferred with a minimum of 15+ years of experience in medical device design and development, including experience as a technical lead or project manager. Deep understanding of catheter mechanics, materials (polymers and metals), and bonding methods. Experience developing Class III implantable medical devices. Experience developing structural heart medical devices within an R&D environment. Strong understanding of mechanical engineering principles and methodologies. Leadership, task planning, and sub-team management experience. Strong communication, presentation, and technical writing skills, with the ability to effectively convey technical concepts and project plans to stakeholders at all levels. Knowledge of applicable standards including ISO 5840, ISO 13485, ISO 14971, ISO 10555, and ISO 10993. Strong design experience with CAD modeling software such as SolidWorks and/or Creo. Ability to create engineering specifications, technical drawings, and bills of material. Experience with manufacturing and assembly of complex prototypes. Experience with design verification planning, testing, and reporting to support early feasibility clinical studies and regulatory submissions. Strong data analysis and statistical skills using tools such as Minitab, JMP, or MedStat to support engineering decisions and regulatory documentation.

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