The Senior Manager, R&D Systems Engineering will lead the systems engineering function supporting development of a 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. The successful candidate will play a critical role in advancing the DurAVR system through clinical evaluation and into commercial scale manufacturing.
Requirements
- 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.
- 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.
Benefits
- Medical, Dental, and Vision Plans
- Flexible Spending Account (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
