Staff Systems Engineer

3 months ago

Pleasanton, United States Abbott Laboratories Full time

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. Youâll 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 bachelorâs 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

We are recruiting a Staff Systems Engineer to join our Abbott Heart Failure team in Pleasanton, CA, where we are focused on helping people with heart failure manage their health and ultimately change and save lives.  The engineer will be primarily working on the CardioMEMS HF portfolio, which remotely monitors changes in pulmonary artery (PA) pressure, an early indicator of the onset of worsening heart failure, to aid physicians in preventing worsening heart failure, lower heart failure mortality rates, and improve quality of life for our heart failure patients.  The role is responsible for driving the systems engineering for a wide range of CardioMEMS products including implantable sensors, external reader systems used by clinicians and patients, mobile application software, and cloud-based web applications.  This person will help to drive and lead the development of new programs and next generation products, focusing on assessing risk and influencing requirements, design, and testing as a result of risk management.

What you will do:

  • Conduct and drive risk management activities within R&D, including various types of FMEA documentation.  Conduct and lead risk brainstorming sessions. 

  • Develop comprehensive understanding of existing and planned system and detailed designs in order to document and drive risk control measures and mitigators.

  • Identify, implement, educate, and share improved tools and methods for risk documentation.  Influence style and language used in risk documentation to ensure systematic and thorough risk coverage. 

  • Participate in product definition, system architecture, requirements writing, requirements management, requirements analysis, System V&V, and design control documentation, from design conception to launch.

  • Participate and drive systems level decision making, accounting for and prioritizing critical needs, risks, and requirements and assessing against various options and solutions.

  • Lead the planning of system engineering tasks, especially risk management tasks, including timelines, budgets, and prioritization.

  • Perform system level characterization of devices through development to refine requirements and finalize the design for System V&V.  Collect, organize, analyze, document, and present results.

  • Plan, execute, and/or lead System V&V testing, data analysis, and documentation.

  • Communicate effectively to cross-functional teams and senior management.

  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. 

  

Required Qualifications:

  • Bachlerâs Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or related discipline

  • 8+ years of in a similar position, including systems engineering and integration experience (integrating all system components - electrical, mechanical, software), system architecture, requirement/user need gathering, end-to-end (ideation to commercialization) technical product development experience, and/or system-level verification

  • Experience working in new product development of medical device industry

  • Experience focused on risk management activities for regulated medical device, especially with FMEA-style risk assessments  

  • Excellent verbal and written communication skills, with ability to communicate to all levels of the organization

  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment

Preferred  Qualifications:

  • Advanced Degree in Engineering (Mechanical, Computer, Electrical, or Software), Computer Science, or related discipline

  • Experience and expertise with systems consisting of hardware, software, mobile app, and cloud components

  • Experience and expertise with systems with RF, electromagnetics, ASICs, Bluetooth, and NFC technologies

  • Class III implantable medical device experience, specifically supporting heart failure and/or cardiovascular systems and experience with biologic sensors (flow, pressure, EKG, etc)

  • Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs



The base pay for this position is $109,300.00 â $218,500.00. In specific locations, the pay range may vary from the range posted.

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