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Senior Compliance Software Engineer (Product)

Abbott is a global healthcare leader that helps people live more fully at all stages of life, with leading businesses in diagnostics, medical devices, nutritionals and branded generic medicines.
Alameda, CA, USA
$98,000 - $196,000
Backend
Senior Software Engineer
In-Person
5,000+ Employees
5+ years of experience
Healthcare

Job Description

Abbott, a global healthcare leader with over 114,000 employees serving more than 160 countries, is seeking a Senior Compliance Software Engineer to join their Diabetes Care division in Alameda, California. This role offers an exciting opportunity to lead software quality assurance efforts for medical device applications and firmware.

The position combines technical software expertise with regulatory compliance, requiring deep understanding of FDA QSR, ISO guidelines, and 21 CFR Part 11 requirements. You'll be responsible for ensuring that Abbott's digital health products meet strict quality and regulatory standards while maintaining efficient development processes.

As a senior member of the Software Quality Assurance team, you'll review system specifications, verification test cases, and validation protocols, while coordinating with cross-functional teams to maintain high quality standards. The role requires 5-8 years of software quality assurance experience, with particular emphasis on medical device testing and Agile methodologies.

Abbott offers an impressive benefits package including free medical coverage, a generous retirement plan, and innovative education benefits like the Freedom 2 Save program for student debt and FreeU for earning a bachelor's degree. The company is consistently recognized as a great place to work globally, particularly for diversity and working mothers.

The salary range of $98,000 to $196,000 reflects the senior nature of the position and Abbott's commitment to competitive compensation. This role provides an excellent opportunity to work on life-changing healthcare technologies while ensuring they meet the highest standards of quality and safety.

Working at Abbott means joining a company at the forefront of healthcare innovation, where your work directly impacts people's lives through advanced medical devices and diabetes care solutions. The company's strong focus on employee development, comprehensive benefits, and inclusive culture make it an ideal place for long-term career growth in the healthcare technology sector.

Last updated 10 hours ago

Responsibilities For Senior Compliance Software Engineer (Product)

  • Lead Software Quality Assurance (SWQA) team for Abbott Diabetes Care products
  • Review quality system documentation for medical device software
  • Coordinate activities with other engineering disciplines and departments
  • Complete software quality tasks according to Quality System Requirements
  • Review and provide guidance on deliverables including System Specifications, Verification Test Cases, and Validation protocols
  • Coordinate development and maintenance of departmental operating procedures
  • Maintain schedule and drive to meet project goals
  • Act as Non-Product SWQA compliance SME for external/internal audits

Requirements For Senior Compliance Software Engineer (Product)

  • Bachelor's degree, or equivalent experience, in scientific, technical, or engineering discipline
  • 5 to 8 years' experience in Software Quality Assurance and/or Software Testing experience
  • Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11
  • 2-4 years project experience in software testing practices and methodologies including Agile
  • Excellent oral and written communication skills

Benefits For Senior Compliance Software Engineer (Product)

Medical Insurance
401k
Education Budget
  • Free medical coverage via Health Investment Plan (HIP) PPO
  • Retirement savings plan with high employer contribution
  • Tuition reimbursement
  • Freedom 2 Save student debt program
  • FreeU education benefit for bachelor's degree
  • Career development opportunities

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