Staff Engineer, Software Design Quality at Abbott

Burlington, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Experienced Staff Software Quality Engineer
Knowledge of Abbott’s design control requirements and state-of-the-art standards for medical device software development
Ability to serve as a technical representative providing quality oversight for software development projects
Onsite work in Pleasanton, CA or Burlington, MA location
Full-time employment

Responsibilities

Provide oversight of R&D design control deliverables for development of medical product software (Cloud Patient Care Networks, mobile applications and embedded software), non-medical software, and non-product software as part of the Global Design Quality Department
Support software verification and validation activities for new products and software changes in accordance with plans; review and approve requirements, software test case protocols/reports, software development plans, and other system and software documentation
Participate in meetings to evaluate, prioritize, and develop action plans for addressing software defects/bugs captured in the problem resolution systems
Perform risk assessments and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues
Participate in technical and management reviews to ensure design plans, product designs, and deliverables related to product software are met; represent the Global Design Quality Department for final review and approval of project deliverables
Support 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
Work as an individual contributor and provide guidance or oversee work of other Software Quality team members
Support audits and lead quality system improvement activities
Comply with U.S. Food and Drug Administration (FDA) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, and procedures

Skills

Key technologies and capabilities for this role

Software Quality EngineeringDesign ControlsMedical DevicesQuality AssuranceRegulatory ComplianceRisk Management

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides career development opportunities, free medical coverage through the Health Investment Plan (HIP) PPO, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.

Is this position remote or onsite?

This is an ONSITE position based out of Pleasanton, CA or Burlington, MA.

What are the key responsibilities of the Staff Software Quality Engineer?

The role involves providing quality oversight for software development projects, supporting verification and validation activities, reviewing and approving software documentation, participating in meetings to address defects, and performing risk assessments.

What is the company culture like at Abbott?

Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, and living a full life, and is recognized as a great place to work with strong commitments to diversity, working mothers, female executives, and scientists.

What experience makes a strong candidate for this role?

Abbott seeks an experienced Staff Software Quality Engineer with expertise in ensuring medical devices meet design control requirements and state-of-the-art standards, particularly in software for cloud networks, mobile apps, and embedded systems.

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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