Senior Systems Engineer

Diagnostic testing is a compass, providing information that helps in the prevention, diagnosis and treatment of a range of health conditions.

Abbott’s life-changing tests and diagnostic tools give you accurate, timely information to better manage your health. We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.

The position of Senior Systems Engineer is within our Abbott Rapid Diagnostics division located in San Diego, California.  This role will lead requirements analysis, systems traceability to sub-systems, hazard analysis/FMEAs and risk management activities for on-going and next generation of products produced by the division.

WHAT YOU'LL DO:

• Gather/elicit user/customer needs from different stakeholders and translate them into system design, system requirements, and sub-system requirements as applicable (e.g. software).

• Identify system and subsystem level interfaces and document these into interface protocol requirements.

• Assess impact of potential system changes to existing system architecture; identify new architectural elements as needed for new programs

• Create and maintain system traceability among needs, system, sub-system level requirements and risk management artifacts to ensure completeness and fully traceable design history file.

• Responsible for the following minimum deliverables:

  • Requirements Management Plan

  • Requirements Analysis, User Needs, System Requirements, Subsystem Requirements

  • Risk Analysis, Evaluation and Control, Preliminary Hazard Analysis, Device Hazard Analysis, FMEAs (e.g. software, use, design)

• Integrate and/or maintain assigned system engineering deliverables in requirements management tool(s) in use

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices; build productive internal/external working relationships

• Carries out duties in compliance with established business policies

• Other duties as assigned, according to the changing needs of the business

WHAT YOU BRING:

Required:

• Bachelor of Science (M.S. preferred) in Biomedical Engineering, Electrical Engineering, or equivalent, including relevant coursework and/or work experience in product development. 

• 5+ years of experience in product development (comprising electro-mechanical and software pieces).

• Proficient with Medical Device regulations (ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls).

• Expert level requirement elicitation, analysis and documentation skills.

• Ability to moderate requirements engineering discussions and work as a bridge among different engineering departments and global stakeholders.

• Experience architecting and allocating requirements across multiple subsystems.

• Experience with Preliminary Hazard Analysis (PHA), Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA).

• Experience setting up, configuring and using enterprise requirements management systems (e.g.: Jama, IBM DOORs, Polarion) is a plus.

• Strong written, verbal, interpersonal and presentation skills.

Preferred:

• Familiarity with Human Factors and Usability Engineering standards and guidelines (AAMI/ANSI HE75, ISO/IEC 62366, UCM 259760).

• Experience writing Use cases, creating Storyboards and using Voice-of-Customer (VOC) techniques to facilitate requirements gathering efforts (Interviews, Surveys, KJ Analysis, CTQ, AHP, Kano Analysis, and Critical Parameter management).

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:  http://www.abbottbenefits.com/pages/candidate.aspx

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.