Director R&D

Role Summary

Own the R&D strategy and execution for Class III cardiovascular devices from concept through design transfer and post-market improvements. Lead a high‑performing, cross‑functional team to deliver safe, effective, and manufacturable products on time and within budget while meeting global regulatory requirements.

Key Responsibilities

• Strategy & Portfolio
  • Define R&D roadmap aligned to clinical needs, market strategy, and risk/cost profiles.
  • Prioritize pipeline and resource allocation; manage stage‑gate and design governance.
• Product Development
  • Lead systems engineering, requirements flow‑down, risk management (ISO 14971), and design controls (21 CFR 820.30, ISO 13485).
  • Oversee verification/validation (V&V), usability (IEC 62366), biocompatibility (ISO 10993), and design transfer to manufacturing.
  • Drive DFM/DFA, reliability engineering, and materials/process selections (e.g., nitinol, polymers, coatings).
• Quality & Compliance
  • Ensure adherence to QMS, DHF completeness, change control, and traceability.
  • Partner with Regulatory for global submissions (e.g., FDA PMA/supplements, EU MDR CE Mark).
• Clinical & Risk
  • Collaborate on pre‑clinical and clinical evidence plans; support risk/benefit justifications and CAPA inputs from post‑market data.
• Supplier & Operations Interface
  • Align with Supplier Quality on component specifications, special processes, and validation (IQ/OQ/PQ).
  • Support process characterization, test method validation, and sustaining engineering.
• Leadership
  • Build and mentor a diverse R&D team; elevate technical rigor, problem solving, and execution discipline.
  • Manage budgets, schedules, and KPIs; communicate program status to executives and the board.

Minimum Qualifications

• BS in Engineering or related field; 10+ years in medical device R&D with 5+ years leading teams.
• Proven Class III cardiovascular device experience (e.g., catheters, implants, delivery systems, pumps, or valves).
• Demonstrated mastery of design controls, risk management (ISO 14971), verification/validation, and design transfer.
• Track record delivering products under FDA (21 CFR 820) and ISO 13485; familiarity with EU MDR.
• Strong cross‑functional leadership, stakeholder communication, and program management.

Preferred Qualifications

• MS/PhD in Engineering; PMP or equivalent.
• Experience with nitinol, catheter systems, implantable materials, and specialized processes (molding, machining, coatings).
• Knowledge of IEC 60601/62304 (if applicable), IEC 62366, ISO 10993, and reliability/HALM methods.
• Background in human factors, pre‑clinical testing, and clinical collaboration.

Success Metrics (KPIs)

• On‑time design milestones and design transfer readiness
• First‑pass V&V success rate and issue closure cycle time
• Audit/inspection outcomes and DHF completeness
• Cost/quality targets (COGS, yield, field reliability, complaint rates)
• Talent retention, skill development, and engagement

Travel

• ~15-25% to suppliers, CMOs, pre‑clinical sites, and clinical/procedure observations.