Staff Design Assurance Engineer
Diabetes Youth Families
CloudCyber Security
Senior Software Design Assurance Engineer
Abbott
full-time
Posted on:
Location Type: Hybrid
Location: Pleasanton • California, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $86,700 - $173,300 per year
Job Level
Senior
Tech Stack
Cyber Security
About the role
- Provides technical and quality system guidance related to establishing software requirements.
- Provide quality oversight for software verification and validation activities for new products in accordance with design planning procedures.
- This includes, but is not limited to, reviewing and approving software test case protocols and reports, review of software development plans, and review of other system and software documentation.
- Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development.
- Leads risk evaluation and associated management activities related to software development including Risk assessments (e.g. FMEA), product risk analysis, and mitigation of software issues.
- Participates in technical and management reviews to ensure design plans, product design and deliverables related to product software are met.
- Represent the quality engineering function for the review and approval of designated design outputs.
- Provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
- May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.
- Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.
- Maintains a strong, collaborative partnership with cross functional team members especially with R&D.
- Works as an individual contributor and may provide guidance or oversee work of other QE team members.
- Develop and conduct training of company personnel for the divisional software development and validation program.
- Support audits and lead quality system improvement activities.
Requirements
- Bachelor’s degree in Engineering or 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 ability to effectively communicate at multiple levels in the organization.
Benefits
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
software requirementssoftware verificationsoftware validationrisk assessmentFMEAproduct risk analysisquality oversightsoftware test case protocolsdocumentation reviewtraining development
Soft skills
communicationcollaborationleadershipproblem resolutionorganizational skillsindividual contributorguidancetrainingcross-functional teamworkquality system improvement
Certifications
Bachelor’s degree in EngineeringBachelor’s degree in Technical Field
