Staff Engineer, Software Design Assurance (Medical Device)

JOB DESCRIPTION:

Working at Abbott

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 or Burlington MA location 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. TheStaff Engineer Software Design Quality will serve as a technical representative providing quality oversight for Software Development projects. TheStaff Engineer Software Design Quality is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software.

What Youll Work On

• 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
• 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
• 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.

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.

Preferred Qualifications

• Experience using requirements management tools (e.g. DOORS) and using problem reporting systems (e.g. JIRA).
• Hands-on experience with FMEA/risk management.
• Experience developing or maintaining design controls for software development.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an

Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

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

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