EPM Scientific
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 timeAudit/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.
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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 timeAudit/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.
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