Senior Designer
AlphaHire
Design Assurance Engineer
Diabetes Youth Families
full-time
Posted on:
Location Type: Hybrid
Location: San Diego • California • 🇺🇸 United States
Visit company websiteSalary
💰 $75,600 - $113,400 per year
Job Level
JuniorMid-Level
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, mobile applications, cloud-based systems, and cybersecurity.
- Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
- Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements.
- Collaborate with Project Management to support the Design Control process and Continuous Improvement initiatives to optimize our SW Development processes.
- Serve as the Design Control expert to software development organization.
- Develop and deliver Design Control training for the software development organization.
Requirements
- A minimum of 2-5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
- BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience.
- Master’s degree preferred.
- Experience with medical device software development.
- Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and SW Tools.
- Experience with software mobile applications, cloud-based systems, and cybersecurity.
- 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
- Travel as required to support business needs
- Hybrid working arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Design ControlSoftware DevelopmentQuality AssuranceRisk ManagementMedical Device Software DevelopmentValidationCybersecurityCOTS SoftwareContinuous ImprovementTraining Development
Soft skills
CollaborationLeadershipCommunicationOrganizational Skills
Certifications
BS DegreeMaster's DegreeISO 13485IEC 62304FDA 21 CFR Part 820
