Senior Software Design Assurance Engineer at Abbott

Pleasanton, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Experience in software quality engineering methodologies and providing quality engineering support for software
Focus on software design quality and regulatory compliance (not Software QA or Test Engineering)
Ability to provide technical and quality system guidance related to establishing software requirements
Knowledge of US FDA regulations, other country regulatory requirements, company policies, and procedures
Strong collaborative partnership skills with cross-functional team members, especially R&D
Ability to work as an individual contributor and provide guidance or oversee work of other QE team members
Capability to develop and conduct training for company personnel on divisional software development and validation programs
Experience supporting audits and leading quality system improvements

Responsibilities

Provide quality oversight for software verification and validation activities for new products in accordance with design planning procedures, including reviewing and approving software test case protocols and reports, software development plans, and other system and software documentation
Lead meetings to prioritize, review, and/or approve action plans for addressing issues captured in problem resolution systems during development
Lead risk evaluation and associated management activities related to software development, including risk assessments (e.g., FMEA), product risk analysis, and mitigation of software issues
Participate 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 review and approval of designated design outputs
Provide quality oversight for non-product software validation by assessing the need for validation and preparing/supporting protocols, reports, and other documentation as required
Support product cybersecurity assessments in conjunction with a cross-functional team
Comply with US FDA regulations, other country regulatory requirements, company policies, and procedures
Maintain a strong, collaborative partnership with cross-functional team members, especially R&D
Provide technical and quality system guidance related to establishing software requirements

Skills

Key technologies and capabilities for this role

Software Quality EngineeringDesign AssuranceQuality EngineeringSoftware VerificationMedical Device SoftwareProduct Development

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this position remote or does it require working from an office?

This position works out of the Pleasanton, CA or Burlington, MA locations.

What are the main responsibilities of the Senior Software Design Assurance Engineer?

The role involves providing technical and quality system guidance for software requirements, quality oversight for software verification and validation, leading meetings for issue resolution, and leading risk evaluation and management activities related to software development.

What is Abbott's company culture like?

Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, career development in an international company, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What experience is ideal for this Senior Software Design Assurance Engineer role?

Ideal candidates have experience in software quality engineering, regulatory compliance, providing quality oversight for verification and validation, leading risk management like FMEA, and supporting product development in a medical device context, particularly in heart failure solutions.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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