Sr Manager, R&D Systems Engineering

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.
• 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.

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