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Abbott · 1 day ago

Staff Engineer, Design Assurance- Software

United States - California - Pleasanton

Full-time

Onsite

Lead/Staff

$99K/yr - $199K/yr

8+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking an experienced Staff Engineer, Software Design Quality to ensure their medical devices meet design control requirements and standards. This role involves overseeing software design assurance for safety-critical systems and collaborating with R&D teams to deliver effective Class III medical devices.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Own software design assurance for new products and significant changes across the full development life cycle; plan and lead design control activities, ensuring complete, auditable traceability from user needs through requirements, architecture, implementation, verification, validation, and release

As part of the Global Design Quality Department, 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

Define and approve verification and validation strategies proportionate to software safety classification per IEC 62304; review and approve software development plans, requirements, test protocols and reports, cybersecurity tests, and associated documentation for embedded, mobile, and cloud components

Support software verification and validation activities for new products and software changes in accordance with plans. Review and approve of 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

Lead risk management for software and system hazards in accordance with ISO 14971, including risk management plans, hazard analyses, software FMEAs, fault trees as appropriate, benefit‑risk evaluations, risk controls, and production/post‑production feedback integration; ensure EU MDR expectations are met for software (including Rule 11 implications) and that EN ISO 14971 harmonization notes are applied where relevant

Provide quality oversight for defect and change control processes, chair or co‑lead software defect triage as needed, ensure risk‑based disposition of nonconformances and field issues, and lead or support CAPAs to effective closure with robust verification of effectiveness. Peer leaders emphasize this as core to the role in high‑reliability portfolios

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

Mentor engineers in design controls, software life‑cycle best practices, cybersecurity by design, and risk management; influence design quality strategy and standard work across programs, helping the organization succeed through FDA’s QMSR transition while sustaining compliance to current QSR where applicable prior to the effective date

Prepare for and participate in internal and external audits and regulatory inspections; ensure Design History Files and EU Technical Documentation are complete, consistent, and inspection‑ready throughout development and transfer to manufacture

Comply with U.S. Food and Drug Administration (FDA) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, and procedures

Qualification

Software Design Quality EngineeringFDA RegulationsISO 13485IEC 62304Medical Device Software DevelopmentRisk ManagementVerificationValidationStakeholder ManagementLeadershipMentoring

Required

Bachelor's degree, or equivalent experience, in a scientific, technical, or engineering discipline

Minimum 8 years of Software Development and Design Quality Engineering experience or an equivalent combination of education and experience

Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (e.g., 62304), EU Medical Device Regulations and MDSAP

Experience with medical device software development lifecycle for Cloud-based networks and/or mobile applications

Demonstrated leadership as a quality core‑team member on complex programs involving mobile and cloud components; proficiency reviewing and approving requirements, architecture, verification/validation evidence, and risk files; fluency with defect and change control processes and audit practices seen at leading OEMs

Preferred

Experience validating non‑product software and digital toolchains using FDA's CSA approach, including cloud/SaaS platforms used in production and quality systems

Strategic quality leadership that elevates design‑in quality and patient safety; the ability to influence design and product security strategy across disciplines; a mentoring mindset that grows software quality and risk management capabilities in the team; and calm, fact‑based execution during audits, escalations, and critical defect management. These are consistent with expectations for senior/staff software design assurance roles in top global device companies

Leadership experience coaching teams through design assurance gates for multi‑site, multi‑component systems; strong stakeholder management with R&D, Clinical, Regulatory, Security, Manufacturing, and Post‑Market Surveillance partners. Peer postings highlight this cross‑functional leadership as a differentiator for senior/staff roles

Hands-on experience with FMEA/risk management

Experience developing or maintaining design controls for software development