Senior Software Design Assurance Engineer, Medical Device

Abbott • Pleasanton, CA

73d

About The Position

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: 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. 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. This position works out of our Pleasanton, CA, Atlanta, GA, or Burlington, MA locations in the Heart Failure division. In Abbott’s Heart Failure business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. The Senior Software Design Assurance Engineer is responsible for supporting product development of for executing and maintaining software quality engineering methodologies and providing quality engineering support for software. The Senior Software Design Assurance Engineer position focuses primarily on software quality but also supports other aspects of product development based on experience. Note: This role focuses on software design quality and regulatory compliance. It is not a Software QA or Test Engineering function.

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.

Nice To Haves

• Advanced degree.
• Previous quality engineering experience and demonstrated use of quality tools/methodologies.
• Experience working in a broader enterprise/cross-division business unit model.

Responsibilities

• 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.
• Additional responsibilities may be assigned as needed.

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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees