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

Rapsys Technologies Pte Ltd.; Iowa; On-site; USD 120,000 - 180,000; Full time

Job summary

Rapsys Technologies Pte Ltd. in the United States (Iowa) seeks a Senior Systems Engineer to lead requirements development, system architecture, integration, and verification for new radiation therapy equipment.

The role involves translating clinical needs into robust requirements, developing architecture and technical specs, and ensuring traceability and risk analysis across design and manufacturing stages. Collaboration with R&D, Quality, Regulatory, and Clinical teams is essential.

Qualifications

• Bachelor’s or Master’s degree in Electrical or Systems Engineering or related discipline.
• 10–15+ years of relevant engineering experience.
• Expertise in complex electromechanical systems and architecture.
• Strong experience in requirements management, verification/validation, and risk analysis.

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, PHA, FMEA, and DFMEA.
• Develop verification strategies, test plans, protocols, and acceptance criteria.
• Support regulatory documentation, 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

Medical device standards

Education

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

Job description

Seeking a Senior Systems Engineer to lead requirements development, system architecture, integration, and verification activities for new radiation therapy equipment.

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.