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R&D Principal Engineer
Job in
Alpharetta, Fulton County, Georgia, 30004, USA
Listed on 2026-09-02
Listing for:
Avanos Medical
Full Time
position Listed on 2026-09-02
Job specializations:
-
Engineering
Biomedical Engineer, Medical Device Industry, Regulatory Compliance Specialist, Product Engineer
Job Description & How to Apply Below
Avanos Medical seeks an R&D Principal Engineer to lead development of advanced medical devices that improve patient outcomes in pain management and chronic care. In this role, you will own end-to-end product development from concept through verification, validation, and design transfer, ensuring compliance with FDA, ISO, and IEC standards. You will translate clinical needs into requirements, guide system architecture, and oversee risk management activities.
Collaborating cross-functionally with clinical, quality, regulatory, and manufacturing teams, you will mentor engineers, drive design reviews, and champion innovation, reliability, and patient safety across global programs.
Responsibilities
- Lead end-to-end development of medical devices from concept through design transfer
- Translate clinical and market needs into engineering requirements and system architecture
- Ensure designs comply with FDA, ISO, IEC, and relevant medtech regulations and standards
- Plan and execute verification, validation, and risk management activities
- Drive design reviews, documentation, and design history file quality
- Collaborate with clinical, quality, regulatory, and manufacturing teams on product development
- Mentor and coach junior engineers and provide technical leadership
- Support design for manufacturability and scale-up with operations teams
- Analyze field performance, complaints, and post-market data to improve products
- Champion innovation, patient safety, and continuous improvement across R&D programs
Required Skills
- Medical device product development
- Design controls (FDA, ISO 13485)
- Systems engineering and requirements management
- Risk management (ISO 14971)
- Verification and validation planning and execution
- CAD and engineering analysis tools
- Design for manufacturability and reliability
- Regulatory and quality compliance (FDA, IEC, ISO)
- Project and technical leadership
- Statistical analysis and test method development
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