Senior Mechanical Engineer - Valve Team

Anteris Tech•Maple Grove, MN

46d

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. The Senior Mechanical Engineer will play a key role in the design, development, and testing of a next-generation transcatheter heart valve system and its accessory components. This position requires strong technical and analytical skills, creativity, and independence to deliver innovative solutions in a regulated medical device environment. Working collaboratively with cross-functional teams and external partners, the Sr Mechanical Engineer will contribute throughout the product lifecycle—from concept development and simulation through design verification, regulatory submission support, and product launch.

Requirements

Proven experience designing and developing mechanical assemblies, preferably for Class III medical devices.
Strong understanding of mechanical engineering principles and methodologies.
Proficiency with FEA/CFD tools (Abaqus, Ansys) and 3D CAD software (SolidWorks, Pro/ENGINEER).
Knowledge of ISO 5840 and related medical device design standards.
Hands-on experience with Design Verification planning, testing, and reporting.
Experience performing statistical analysis and preparing test data for regulatory submission (e.g., Minitab, MedStat).
Ability to interpret engineering drawings, develop Bills of Materials, and create robust documentation.
Strong communication, presentation, and technical writing skills.
Experience working with external manufacturers and custom component suppliers.
Proficiency in Microsoft Office and general engineering documentation tools.
PhD in Mechanical Engineering, Physical Science, or related discipline; or Master’s degree with 2+ years of relevant experience; or Bachelor’s degree with 4+ years of relevant experience; or 8+ years of medical device product design and development experience.

Nice To Haves

Familiarity with FDA Quality System Regulations, ISO 13485, ISO 14971, and ISO 62304 standards.
Experience with Early Feasibility testing and submissions.
Knowledge of cardiac anatomy and physiology.
Understanding of systems engineering principles and design transfer processes.
Exposure to manufacturing, quality assurance, and risk management.
Demonstrated ability to plan tasks, lead sub-teams, and manage technical priorities.

Responsibilities

Serve as a primary technical contributor in the design and development of new products and product improvements.
Perform mechanical design, testing, and documentation to meet compliance and product requirements in alignment with customer and regulatory expectations.
Work both independently and cross-functionally to develop creative, data-driven technical solutions to complex problems.
Lead troubleshooting and root-cause analysis activities related to implantable and/or external instruments and systems.
Develop and communicate detailed design and test plans, deliverables, and project status updates.
Generate and maintain design control documentation, including procedures, reports, and records, consistent with a regulated environment.
Support Quality and Regulatory teams by ensuring design documentation meets applicable standards and company requirements.
Interface with vendors and contract manufacturers to ensure component quality, resolve design challenges, and facilitate design transfer.
Contribute to design transfer activities from R&D to manufacturing and sustainment engineering.
Effectively manage time and resources to achieve project milestones.