Systems Lead, Sustaining

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.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

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 Systems Engineering Lead will work from our Alameda, CA headquarters. This person will lead a team sustaining on market products. Key responsibilities will include developing best practices for updating risk assessments, design documentation, requirements specifications, and other design history file documents to address newly identified risks and requirements of emerging standards. Identify and resolve on market issues. Lead multiple systems engineering activities. Develop cross-functional working relationships and provide effective communication to Senior Management .

WHAT YOU'LL DO

• Lead/perform updates to product definition, requirements, risk analysis, hazard analysis, product test and evaluation, System V&V, and/or design control documentation.
• Develop ways to address impact of emerging standards impact on existing products
• Lead/conduct system level assessment of complex systems including wearable, handheld, and phone application components.
• Lead/perform analysis and integration of information from MAUDE (Manufacture and User Facility Device Experience) into product documentation and project plans.
• Cultivate 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.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

• 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 working with products with wireless communication, such as Bluetooth Low Energy.
• Experience with mobile software or application development, including software architecture knowledge.
• 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.
• Ability to conduct thorough data analytics & implement data-driven solutions.
• Strong analytical & problem-solving skills.
• Ability to provide guidance to junior team members.

Preferred

• Experience creating risk assessments to drive testing to standards such as 60601-1, 60601-1-2.
• Understanding of agile development and test methodologies
• 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 $125,700.00 - $251,500.00. In specific locations, the pay range may vary from the range posted.