Medical Device TPM - NPD & Launch Leader

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

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