Senior Software Design Assurance Engineer
$78,000–$156,000 year
On-sitePleasanton, California, United States or Burlington, Massachusetts, United States
Job Summary
Senior Software Design Assurance Engineer at Abbott accountable for software quality engineering across product development. Responsibilities include providing quality oversight for software verification and validation activities, reviewing software test case protocols and reports, reviewing development plans and other documentation, leading risk evaluation and mitigation (e.g., FMEA), participating in design and management reviews to ensure software deliverables meet requirements, and supporting non-product software validation, cybersecurity considerations, audits, and quality system improvements. Collaborates with cross-functional teams including R&D, develops and conducts training on the divisional software development and validation program, ensures compliance with US FDA and other regulatory requirements, and may guide other QE team members. Requires a Bachelor’s degree in engineering or technical field and at least 5 years of related experience; advanced degree and broader cross-division experience are preferred.
Required Qualifications
- Bachelor’s degree in engineering or a technical field
- Minimum of 5 years related work experience in Quality or a related field
- Knowledge of regulations, standards, and guidance affecting medical software and non-medical device software development
- Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization