Principal R&D Systems Engineer

Anteris Tech•Maple Grove, MN

1d•$140,000 - $160,000

About The Position

Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease. We are currently developing a new class of TAVR designed to mimic the performance of a healthy aortic valve. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. We are seeking an experienced Principal R&D Systems Engineer with extensive medical device development experience to serve as the lead systems engineer on our novel transcatheter aortic valve replacement system. This role is responsible for defining and maintaining the system architecture, translating clinical and user needs into engineering requirements, and guiding cross-functional teams through the design, integration, and verification of a complex Class III medical device system. The successful candidate will play a critical leadership role in advancing our novel TAVR system through clinical evaluation and commercial readiness. This individual will partner closely with engineering, clinical, regulatory, quality, and external partners to ensure the system design meets performance, safety, and regulatory expectations. The ideal candidate combines deep technical expertise with strong systems thinking and the ability to align diverse teams around a clear technical vision. If you are passionate about solving complex engineering challenges and developing innovative structural heart technologies that improve patient outcomes, we encourage you to apply. At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Requirements

Bachelor’s degree in engineering required, ideally Mechanical or Biomedical; MS preferred
Minimum of 10+ years of experience in medical device design and development, including technical leadership responsibilities.
Experience developing complex medical devices in a regulated R&D environment.
Strong understanding of systems engineering principles and methodologies including requirements management, system architecture, and design integration.
Experience with design verification and validation planning, testing, and reporting to support regulatory submission
Knowledge of FDA Quality System Regulations and international standards including ISO 13485, ISO 14971, and ISO 62304 standards.
Demonstrated ability to lead cross-functional engineering teams and guide technical decision-making.
Strong design experience with CAD modeling software, i.e., SolidWorks and/or Creo. Ability to create engineering specifications & technical drawings.
Strong analytical and data interpretation skills using tools such as Minitab, JMP, or other equivalent software.
Excellent technical writing, verbal, presentation and communication skills
Proficient with standard engineering documentation tools and Microsoft Office applications

Nice To Haves

Structural heart med device development, particularly minimally invasive catheter-based heart valve repair or replacement devices.
Familiarity with cardiac anatomy, physiology, and procedures.
Knowledge of catheter design and manufacturing processes.
Familiarity with human factors and usability engineering principles.
Knowledge of biocompatible materials and their mechanical properties.
Experience collaborating with external suppliers and contract manufacturing partners to develop custom components.
Experience supporting preclinical studies and early feasibility clinical programs.
Leadership, task planning, and sub-team management skills and experience.
Experience working in a startup or emerging technology environment

Responsibilities

Serve as the technical systems lead for a structural heart device program, responsible for defining and maintaining overall system architecture and performance requirements.
Partner closely with physicians, field team and marketing to identify and understand clinical / user needs and translate into robust system-level requirements.
Lead development and management of design inputs, system specifications, and requirement hierarchies across subsystems including implant, delivery system, and accessories, ensuring traceability throughout the product development lifecycle.
Guide cross-functional engineering teams in the design and integration of mechanical subsystems (catheters, valves, accessories) into a cohesive system design, ensuring designs are optimized for system level performance by owning the system design interfaces.
Lead mechanical design, generation of engineering documentation, and testing to meet product requirements and satisfy customer needs.
Develop and validate system level test methods and lead system level performance testing.
Develop and communicate system-level verification and validation strategies.
Works independently as well as with project teams to trouble shoot complex design challenges and develop technical solutions to complex problems that require ingenuity and creativity.
Support and communicate decisions through robust engineering practices and data analysis.
Collaborate with cross functional teams to drive product development from concept to commercialization, while following documented design control processes, conducting risk management, and ensuring regulatory compliance.
Drive continuous improvement of internal product development processes and systems engineering practices.