Technical Program Manager (TPM) – Medical Devices / NPD

Intellectt Inc; Palo Alto (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Health Insurance

401(k) retirement plan

Paid Time Off

Job summary

Intellectt Inc. in Palo Alto seeks a proactive Technical Program Manager to lead end-to-end medical device NPD programs from concept through commercialization.

You will develop integrated schedules, milestones, budgets, and resource plans while coordinating cross-functional teams across systems, hardware, software, firmware, regulatory, clinical, manufacturing, and supply chain. You will govern programs with executive reporting, manage risks, facilitate design reviews, and ensure compliance with

Qualifications

• Experience leading medical device NPD programs end-to-end.
• Knowledge of Design Controls and regulatory requirements.
• Strong risk management and cross-functional collaboration.

Responsibilities

• Lead end-to-end medical device NPD programs from concept to commercialization.
• Develop integrated program schedules, milestones, budgets, and resource plans.
• Coordinate Systems, Hardware, Software, Firmware, Mechanical, Quality, Regulatory, Clinical, Manufacturing, and Supply Chain teams.
• Manage program governance, executive reporting, and stakeholder communications.
• Identify and mitigate technical, regulatory, operational, and schedule risks.
• Facilitate design reviews and ensure compliance with medical device Design Controls.
• Support FDA, ISO 13485, ISO 14971, and IEC 62304 compliance.
• Drive verification, validation, design transfer, and product launch activities.
• Manage vendors, suppliers, and external development partners.
• Resolve critical-path challenges and improve program execution.

Skills

Technical Program Management

Medical device NPD

Design Controls

Risk management

V&V

Design transfer

FDA regulations

ISO 13485

Stakeholder management

Cross-functional leadership

Job description

• Lead end-to-end medical device NPD programs from concept through commercialization.
• Develop integrated program schedules, milestones, budgets, and resource plans.
• Coordinate Systems, Hardware, Software, Firmware, Mechanical, Quality, Regulatory, Clinical, Manufacturing, and Supply Chain teams.
• Manage program governance, executive reporting, and stakeholder communications.
• Identify and mitigate technical, regulatory, operational, and schedule risks.
• Facilitate design reviews and ensure compliance with medical device Design Controls.
• Support FDA, ISO 13485, ISO 14971, and IEC 62304 compliance.
• Drive verification, validation, design transfer, and product launch activities.
• Manage vendors, suppliers, and external development partners.
• Resolve critical-path challenges and improve program execution.

Required Skills:

Technical Program Management, medical device NPD, Design Controls, risk management, V&V, design transfer, FDA regulations, ISO 13485, stakeholder management, and cross-functional leadership.

Preferred:

PMP certification, Class II/III medical devices, hardware/software integrated product development, Agile and traditional program management, and global team management.

Benefits:

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements

Health Insurance:

Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:

A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):

No PTO other than that required by applicable state and local laws

Equal Employment Opportunity:

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.