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Senior Design Quality Engineer – St Paul Tech Center

Abbott Laboratories

This is a Contract position in Newark, NJ posted October 12, 2021.

Abbott is a global healthcare leader that helps people live more fully at all stages of life.

Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Our 109,000 colleagues serve people in more than 160 countries.

EPHF Leading an active lifestyle is important to the many people we serve.

In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.

WHAT YOU’LL DO A Senior Design Quality Engineer, on our design assurance team
– provides ownership of the Design Control deliverables required to support both new product development projects and design change projects Influence the EP Division and lead the DQA project team by working with Product Software Engineers (embedded within R&D) to review code, software architecture and identify possible failure modes/risk control opportunities/security vulnerabilities for complex systems with embedded software.

Own the investigation to define and integrate risk/vulnerability findings by coordinating with R&D through all phases of Software / Firmware design using Quality Assurance principles applicable to FDA/EUMDR-Regulated Class II and Class III Medical Device Software environments (including interconnected software systems).

Participate in software design reviews with focus on unit test, regression tests, test automation, software architecture, cybersecurity, SOUP evaluation and other areas of related to software and cyber security risks to support Risk Management activities.

Support the creation and execution of validation scripts to perform system level testing of our products and report any issues discovered.

Own the risk management and usability documentation such as, Hazard Analysis, Design Failure Mode and Effects Analysis (DFMEA), Task Analysis and Fault Tree Analysis (FTA) incorporating software/firmware and vulnerability findings.

Create and/or review of software, mechanical and hardware DQA documentation as required.

Own the development and documentation of software safety classifications / level of concern rationale.

Lead efforts for Knowledge Sharing or Procedure writing for Software Risk Management Practices.

Support all aspects of DQA activities during internal and external audits, as needed.

Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

May perform other duties as directed EDUCATION AND EXPERIENCE YOU’LL BRING BS in Electrical or Software Engineering.

Minimum of 7 years of Medical device engineering experience, with experience in Medical Device Software and Integrating Systems or 10 years in a related Industry with relevant Software / System Integration experience.

Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, usability engineering and medical device software.

Working knowledge of US and International regulations including 21 CFR part 820, is ideal, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485, EN IEC 62304 and EN ISO 14971.

Strong communication and presentation skills.

Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent), Linux operating systems, C++, JIRA WHAT WE OFFER At Abbott, you can have a good job that can grow into a great career.

We offer: Training and career development , with onboarding programs for new employees and tuition assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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