Technical Program Manager to lead medical device product developme Job Palo Alto area,California USA,Engineering

Job Description & How to Apply Below

Position: Seeking a Technical Program Manager to lead medical device new product developme
Key Responsibilities

Lead systems engineering activities throughout the product development lifecycle.
Translate stakeholder and clinical needs into system and subsystem requirements.
Develop system architecture, functional decomposition, and technical specifications.
Manage requirements traceability, subsystem interfaces, and technical risks.
Lead system integration, prototype bring-up, and performance characterization.
Perform system risk analysis, Preliminary Hazard Analysis (PHA), FMEA, and DFMEA.
Develop verification strategies, test plans, protocols, and acceptance criteria.
Support regulatory documentation, Design History File (DHF) activities, and design transfer to manufacturing.
Collaborate with R&D, Quality, Regulatory, Manufacturing, and Clinical teams.

Required Qualifications and Skills

Bachelor’s or master’s degree in Electrical Engineering, Systems Engineering, or a related discipline.
10–15+ years of relevant engineering experience.
Expertise in complex electromechanical systems, systems architecture, and integration.
Strong experience in requirements management, verification, validation, and risk analysis.
Knowledge of ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366-1.

Preferred Qualifications

Experience with medical devices, radiation therapy equipment, medical linear accelerators (LINACs), imaging systems, or robotics.