Senior Software Design Assurance Engineer
Abbott
Senior Software Design Assurance Engineer, Medical Device
Abbott
full-time
Posted on:
Location Type: Office
Location: Pleasanton • California, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $75,300 - $150,700 per year
Job Level
Senior
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.
- 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.
- Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.
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.
- Expert in IEC 62304 and ISO 14971 standards requirements
- Strong verbal and written communication with ability to effectively communicate at multiple levels in the organization.
Benefits
- Career development with an international company where you can grow the career you dream of.
- 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.
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 analysismitigation of software issuesIEC 62304ISO 14971
Soft skills
communicationleadership