Technical Program Manager – Medical Devices / NPD

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 Technical Program Manager to lead medical device NPD programs from concept through commercialization.

You will coordinate cross-functional teams, manage schedules, budgets and risks, and ensure design controls are followed. The role requires 8+ years in program management, with 5+ in medical devices, knowledge of FDA/ISO 13485, and strong stakeholder leadership.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 8+ years of experience, with at least 5 years in medical devices.
• Strong experience in program management for medical device NPD.
• Knowledge of Design Controls, risk management, V&V, design transfer, FDA regulations, and ISO 13485.
• Excellent stakeholder management and cross-functional leadership.

Responsibilities

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

Skills

Program management

Medical devices

Stakeholder management

Cross-functional leadership

Design Controls

V&V

Risk management

FDA regulations

ISO 13485

Education

Bachelor's degree in Engineering, Life Sciences, or related field

Job description

Seeking a Technical Program Manager to lead medical device new product development programs from concept through commercialization, coordinating technical teams and managing program schedules, budgets, risks, and delivery.

Key Responsibilities

• Lead end-to-end medical device NPD programs.
• Develop integrated 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 adherence to medical device Design Controls.
• Support compliance with applicable FDA regulations, ISO 13485, ISO 14971, and IEC 62304.
• Drive verification, validation, design transfer, and product launch activities.
• Manage vendors, suppliers, and external development partners.
• Resolve critical-path issues and improve program execution.

Required Qualifications and Skills

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 8+ years of relevant experience, including 5+ years in medical devices.
• Strong experience in technical program management and medical device NPD.
• Knowledge of Design Controls, risk management, V&V, design transfer, FDA regulations, and ISO 13485.
• Strong stakeholder management and cross-functional leadership skills.

Preferred Qualifications

• PMP certification.
• Experience with Class II/III medical devices.
• Experience developing products that integrate hardware and software.
• Familiarity with Agile and traditional program management methods.
• Experience managing global teams.