| Location | Palo Alto, CA |
| Salary | $45–$50 |
Lead end-to-end medical device New Product Development (NPD) programs from concept through commercialization.
Develop integrated program plans, milestones, schedules, budgets, and resource plans.
Coordinate cross-functional teams, including Systems, Hardware, Software, Firmware, Mechanical, Quality, Regulatory, Clinical, Manufacturing, and Supply Chain.
Manage program governance, executive reporting, stakeholder communications, and decision-making processes.
Identify, assess, and mitigate technical, regulatory, operational, and schedule-related risks.
Facilitate design reviews and ensure compliance with medical device Design Controls.
Support compliance with FDA regulations, ISO 13485, ISO 14971, and IEC 62304 standards.
Drive verification, validation, design transfer, and product launch activities.
Manage vendors, suppliers, and external development partners.
Track critical path activities and resolve program execution challenges.
Drive continuous improvement in program management processes and methodologies.
Bachelor's degree in Engineering, Life Sciences, or a related technical field.
8+ years of experience in Technical Program Management, Program Management, or Product Development leadership.
5+ years of experience in Medical Devices, Diagnostics, Digital Health, or regulated healthcare environments.
Proven experience delivering complex New Product Development (NPD) programs through commercialization.
Strong knowledge of Design Controls, Risk Management, Verification & Validation (V&V), and Design Transfer.
Experience working in FDA-regulated and ISO 13485 environments.
Excellent leadership, communication, stakeholder management, and problem-solving skills.
PMP certification or equivalent.
Experience with Class II or Class III medical devices.
Experience in hardware-software integrated product development.
Knowledge of Agile and traditional program management methodologies.
Experience managing global teams and external development partners.
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.