Base Salary
$100k - $200k/yr
Responsibilities
- Lead complex digital health programs spanning cloud platforms, mobile applications, connected devices, data pipelines, and clinical workflows.
- Translate business, clinical, customer, and stakeholder inputs into software and system requirements, functional specifications, development plans, and testing requirements.
- Provide technical leadership and subject-matter expertise on system behavior, implementation trade-offs, customer needs, clinical applications, and applicable technologies.
- Drive standardized engineering methods, design reviews, requirements traceability, validation, and compliance throughout the development lifecycle.
- Contribute to hazard analysis, FMEA, risk assessments, and the translation of risk controls into requirements, architecture, design, and verification or validation plans.
- Coordinate cross-functional stakeholders, prioritize trade-offs, resolve issues, track progress, and deliver high-quality outputs aligned with regulatory expectations.
- Plan and execute department strategy, organize assigned work, and foster collaboration across business, clinical, regulatory, engineering, and other teams.
- Comply with FDA regulations, other regulatory requirements, company policies, and operating procedures.
Requirements
- Bachelor’s degree in software engineering, computer science, or a related engineering field.
- At least 8 years of relevant experience with a bachelor’s degree, at least 6 years with a master’s degree, or equivalent years of education and experience in engineering and sciences.
- Ability to integrate information across clinical medicine, engineering, marketing, and regulatory affairs.
- Preferred experience in the medical device industry and broader enterprise or cross-division business environments.
- Working knowledge of cloud-based platforms such as AWS, Azure, or GCP and mobile application ecosystems.
- Familiarity with standards such as IEC 62304 and ISO 14971 or similar standards.
- Experience with requirements, configuration, and defect management tools such as DOORS and JIRA.
- Ability to work effectively in matrixed, geographically diverse, cross-functional, and changing environments.
- Strong communication, organizational, prioritization, follow-up, multitasking, and deadline-management skills.
Benefits
- Career development opportunities with an international company.
- Employees may qualify for free medical coverage through the Health Investment Plan PPO in the next calendar year.
- Retirement savings plan with a high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit.
- Position based in Pleasanton, California, with a standard work shift and approximately 10% travel.
- Medical surveillance is not required; work includes prolonged sitting and standing periods.
Tech Stack
Categories
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on X @AbbottNews. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Terms of Use: https://www.abbott.com/social-media-terms-of-use.html Privacy Policy: https://abbo.tt/privacy