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Systems Engineering Manager, Sustaining
Systems Engineering Manager, SustainingAbbott Laboratories • Alameda, CA, US
Systems Engineering Manager, Sustaining

Systems Engineering Manager, Sustaining

Abbott Laboratories • Alameda, CA, US
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  • [job_card.full_time]
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Job Description

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 114,000 colleagues serve people in more than 160 countries.

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. You’ll also have access to :

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees
  • via the Health Investment Plan (HIP) PPO
  • 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 bachelor’s 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

The  Systems Engineering Manager, Sustaining  will work within R&D from either our Alameda, CA or Milpitas CA facilities.  Key responsibilities include utilizing telemetry data to understand product performance in the field and maintaining living risk files for on market products.

What you’ll work on

  • Work with product owner, as a customer represent hardware and firmware teams, for ongoing development of telemetry system.
  • Guide analysis of telemetry data to gain insights into product behavior in the field.
  • Effectively communicate with development teams, driving product improvement.
  • Maintaining living risk assessments, design documentation, and other design history file documents to address newly identified risks, emerging standards, and product improvements.
  • Review risk evaluations.
  • Review of medical device reports in MAUDE databases for previously unrecognized risks / hazards. Work with organization to mitigate these risks
  • Work with development teams on feedback learning from sustaining activities.
  • Maintain best practices and drive continuous improvement activities.
  • Cultivate solid working relationships cross functional teams.
  • Investigate complaints from on market products.
  • Write and submit engineering change orders in Agile (a product lifecycle management tool).
  • Provide guidance and / or act as independent review in programs not directly involved.
  • Communicate effectively and participate on cross functional development teams with good negotiating skills to direct multi-disciplinary teams toward solutions.
  • Comply with all applicable Corporate and Divisional Policies and perform other duties as assigned by the Management Team.

    • Required Qualifications

  • Bachelor’s (BS) degree and minimum 10 years of relevant experience in engineering (or MS degree with minimum 8 years experience, or PhD with minimum 6 years of experience).
  • Advanced level of experience with application of medical device risk management per ISO 14971.
  • Experience analyzing system and hardware event logs to diagnose performance, functionality, and operational issues.
  • Experience with mobile software or application development including telemetry.
  • Experience with medical device systems development per FDA and EU design control regulations.
  • Experience with model based systems engineering (MBSE), UML, and SysML.
  • Demonstrated success in technical proficiency, creativity, and independent thought.
  • Strong analytical & problem-solving skills.
  • Ability to provide guidance to junior team members.

    • Preferred Qualifications

  • Experience creating risk assessments to drive testing to standards such as 60601-1, 60601-1-2.
  • Understanding of agile development and test methodologies.
  • Understanding of software development process, bug and feature request tracking.
  • Knowledge of continuous integration & continuous development (CI / CD).
  • Advanced level of knowledge with continuous integration & continuous development (CI / CD).
  • Advanced level of experience with medical device software development per IEC 62304.
  • Experience with IBM Engineering Requirements Management DOORS, Cameo MagicDraw, and 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 :    www.abbottbenefits.com

    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.

    The base pay for this position is $146,700.00 – $293,300.00. In specific locations, the pay range may vary from the range posted.

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