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Technical Program Manager for Medical Device Development
3 weeks ago
About the Position
You will be a technical lead for cross-functional development teams supporting efforts for hardware and embedded software systems. Your expertise in design control, risk management, and software development life cycles will drive compliance to regulatory requirements.
Key Responsibilities:
- Develop and implement design history files and deliverables
- Provide subject matter expertise in risk management activities and design control
- Ensure compliance with software development life cycles and FDA guidance on software contained in 510(k) submissions
- Support cybersecurity risk management efforts
- Provide technical expertise to design quality assurance organizations
