Seeking a Technical Program Manager to lead medical device new product developme

Tap Growth ai; Palo Alto (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Tap Growth ai seeks a senior Systems Engineer to lead the full lifecycle of complex electromechanical medical devices. You will translate clinical needs into robust system requirements, shape architecture, and drive verification and risk analyses.

You will coordinate with R&D, Quality, Regulatory, Manufacturing, and Clinical teams to ensure design transfers and regulatory readiness. The role requires deep expertise in systems engineering, strong knowledge of relevant ISO/IEC standards, and a

Qualifications

• Bachelor’s or master’s degree in Electrical Engineering, Systems Engineering, or a related discipline.

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.

Skills

Systems Engineering

Requirements management

Verification & Validation

Risk analysis

Hardware-Software integration

Regulatory standards

Education

Bachelor’s or Master’s in Electrical Engineering / Systems Engineering or related

Tools

ISO 13485

ISO 14971

IEC 60601

IEC 62304

IEC 62366-1

Job description

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.