Staff Engineer, Design Assurance- Software

JOB DESCRIPTION:

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. Youll 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 bachelors 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.

The Opportunity

This position works onsite out of our Pleasanton CA Burlington MA or Atlanta GA locations in the Abbott Heart Failure Division Global Design Quality Department.

In Abbotts Heart Failure (HF) business were developing solutions to diagnose monitor and manage heart failure allowing people to restore their health and get on with their lives.

We are seeking an experiencedStaff Engineer Software Design Qualityto ensure our medical devices are developed in accordance with Abbotts design control requirements and state of the art standards. This stafflevel role serves as the software design assurance lead for complex safetycritical systems spanning embedded firmware connected devices mobile apps and cloud services. You will embed with R&D as the quality coreteam representative to ensure design controls risk management cybersecurity and verification/validation are planned and executed to deliver safe effective Class III medical devices worldwide. You will operate within a global quality system aligned to FDA 21 CFR Part 820 (transitioning to QMSR aligned with ISO 13485) EU MDR 2017/745 ISO 13485:2016 ISO 14971:2019 and IEC 62304:2006A1:2015.

What Youll Work On

• 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 benefitrisk evaluations risk controls and production/postproduction 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 colead software defect triage as needed ensure riskbased 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 highreliability 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 lifecycle best practices cybersecurity by design and risk management; influence design quality strategy and standard work across programs helping the organization succeed through FDAs 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 inspectionready 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.

Required Qualifications

• Bachelors 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 coreteam 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 Qualifications

• Experience validating nonproduct software and digital toolchains using FDAs CSA approach including cloud/SaaS platforms used in production and quality systems

• Strategic quality leadership that elevates designin 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 factbased 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 multisite multicomponent systems; strong stakeholder management with R&D Clinical Regulatory Security Manufacturing and PostMarket Surveillance partners. Peer postings highlight this crossfunctional leadership as a differentiator for senior/staff roles

• Hands-on experience with FMEA/risk management.

• Experience developing or maintaining design controls for software development.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

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