Sr Manager, R&D Systems Engineering

Anteris Tech•Maple Grove, MN

3d•$160,000 - $195,000

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. The Senior Manager, R&D Systems Engineering will lead the systems engineering function supporting development of our novel transcatheter heart valve (THV) system. This individual will provide technical leadership across the full system architecture, guiding the integration of implant, delivery system, and accessory components into a cohesive Class III medical device platform. This role combines deep technical systems engineering expertise with people leadership, managing and mentoring a growing team of engineers while driving system-level design strategy, verification, and commercialization readiness. The successful candidate will play a critical role in advancing the DurAVR system through clinical evaluation and into commercial scale manufacturing. 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 Mechanical Engineering, Biomedical Engineering, or related engineering discipline.
Minimum of 10 years of medical device product development experience, including experience with Class III implantable devices.
Minimum of 5 years of engineering leadership or team management experience.
Demonstrated experience developing structural heart or transcatheter cardiovascular devices (TAVR, TMVR, or related technologies).
Strong knowledge of medical device development processes, including design controls, risk management, and verification/validation activities.
Experience leading multidisciplinary engineering teams in regulated environments.

Nice To Haves

Master’s degree in Mechanical or Biomedical Engineering.
Direct experience with tissue valve technologies or structural heart implant systems.
Experience developing catheter-based delivery systems and mechanical assemblies.
Proficiency with 3D CAD modeling tools (SolidWorks preferred).
Experience with finite element analysis (FEA) tools such as Solidworks or ANSYS.
Knowledge of polymer design, plastic part design, and injection molding.
Experience developing and executing design verification strategies and system-level testing.
Familiarity with statistical analysis tools such as Minitab for engineering test analysis.
Experience preparing engineering documentation for regulatory submissions.
Strong technical writing, communication, and presentation skills.

Responsibilities

Serve as the functional leader for R&D Systems Engineering supporting the transcatheter heart valve program.
Define and maintain overall system architecture, performance requirements, and interface definitions across device subsystems including implant, delivery system, and accessories.
Translate clinical and user needs into system-level design inputs, specifications, and requirement hierarchies, ensuring traceability throughout the design control process.
Lead cross-functional engineering efforts to ensure mechanical, biological, and delivery system components integrate into a robust and high-performing medical device system.
Drive system-level design decisions through structured engineering analysis, risk assessment, and data-driven evaluation.
Lead the design, development, testing, and documentation of mechanical components supporting the THV system.
Develop and communicate system verification and validation strategies, including system-level test methods and performance testing.
Support early feasibility studies, system characterization, and design optimization activities.
Guide engineering teams in solving complex design challenges requiring innovative technical solutions.
Lead troubleshooting and root cause analysis related to device performance, reliability, and system integration.
Ensure development activities comply with design control requirements for Class III medical devices.
Create and review engineering documentation including design inputs, risk analyses, verification protocols, test reports, and design history file content.
Maintain compliance with applicable standards including FDA Quality System Regulations, ISO 13485, ISO 14971, and ISO 5840.
Support regulatory submissions, clinical trial readiness, and regulatory agency interactions as needed.
Partner with clinical, regulatory, quality, manufacturing, and marketing teams to ensure system design aligns with clinical needs and commercial strategy.
Work closely with manufacturing and operations teams to support design transfer from R&D to manufacturing.
Interface with external partners, contract manufacturers, and suppliers to ensure components meet design requirements.
Build, lead, and mentor a team of high-performing systems and mechanical engineers.
Establish clear technical direction, priorities, and development plans for team members.
Manage engineering resources, budgets, and timelines to achieve program milestones.
Promote a collaborative, high-performance engineering culture focused on innovation, accountability, and continuous improvement.