SunnyvaleFull TimeEngineering
Remotely
risk managementquality engineeringsoftware designfda qsrdesign controlsiso 13485iso 14971electromechanical systems
Job Description
📋 Description
- Support product development from concept through commercialization
- Serve as core team member for cross-functional development teams
- Advise on design control, risk management, and software SDLC
- Ensure products meet Intuitive quality processes and regulatory requirements
- Contribute to design history file and regulatory submissions
- Assist audits and supplier qualifications as needed
🎯 Requirements
- 8+ years in Quality Engineering; 4+ years in electromechanical systems and/or software design
- Strong design control and risk management experience
- Experience with ISO 13485, ISO 14971, FDA QSR
- Ability to navigate quality systems with minimal oversight
- Strong communication with teams and executives
🎁 Benefits
- Equal Opportunity Employer
- Market-competitive compensation with benefits and equity
