Senior Software Design Assurance Engineer
Abbott
Cyber Security
Staff Design Assurance Engineer
Diabetes Youth Families
full-time
Posted on:
Location Type: Hybrid
Location: San Diego • California • 🇺🇸 United States
Visit company websiteSalary
💰 $114,750 - $172,125 per year
Job Level
Lead
Tech Stack
CloudCyber Security
About the role
- Lead Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices
- Ensure compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission
- Collaborate with Project Management to support the Design Control process and Continuous Improvement initiatives to optimize our SW Development processes
- Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management
- Maintain effective communication with the project software engineers to ensure comprehensive documentation
Requirements
- BS degree in an engineering, scientific, computer systems, or quality management curriculum or equivalent experience
- ASQ, CSQE or other software quality certificates are beneficial
- Minimum 8 years work experience in Software Quality Engineering within an FDA, ISO, or other regulated environment
- Experience with software mobile applications, cloud-based systems, and cybersecurity
- Experience in the development and implementation of effective Design Control Systems
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards
- Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for 510(k)
Benefits
- Hybrid working arrangements
- Health insurance
- Professional development opportunities
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
software quality engineeringdesign controlrequirements analysisdefect trackingconfiguration managementdesign and code reviewscloud-based systemscybersecuritymobile applicationscontinuous improvement
Soft skills
leadershipcollaborationcommunicationguidancedocumentation
Certifications
BS degreeASQCSQE
