Senior Medical Device NPD Program Manager

Tap Growth ai; Iowa; On-site; USD 120,000 - 170,000; Full time

Job summary

Tap Growth ai seeks a Technical Program Manager to lead medical device new product development from concept to commercialization in the United States. You will coordinate diverse teams across hardware, software, firmware, regulatory, QA, and manufacturing while managing schedules, budgets, and risks.

You will drive design reviews, ensure compliance with Design Controls, and lead vendor relationships to deliver products on time and within scope.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or 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.

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.

Skills

Program management

Medical devices

Cross-functional leadership

V&V

Design Controls

FDA regulations

ISO 13485

ISO 14971

IEC 62304

Vendor management

Risk management

Education

Bachelor's degree in Engineering/Life Sciences

Job description

Tap Growth ai seeks a Technical Program Manager to lead medical device new product development from concept to commercialization in the United States. You will coordinate diverse teams across hardware, software, firmware, regulatory, QA, and manufacturing while managing schedules, budgets, and risks.

You will drive design reviews, ensure compliance with Design Controls, and lead vendor relationships to deliver products on time and within scope.