Senior Risk Management Engineer

Abbott Laboratories hiring for Senior Risk Management Engineer jobs in Menlo Park, CA, US

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

This position works out of our Menlo Park, California location in the SH division.

Structural Heart Business Mission:  why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

As the Senior Risk Management Engineer, you'll have the chance to assure new or modified products perform the functions intended in a safe manner and establishes compliance with the quality system.They collaborate with clinical, design engineering, regulatory, labeling, and post market surveillance functions to ensure that risk is appropriately mitigated, evaluated, disclosed, and monitored.They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

What You’ll Work On

• Execute and support on-time completion of Risk Management Deliverables.Ability to work with highly complex or specialized projects
• Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback
• Maintain SOPs, Work Instructions, Templates
• Support Product Performance Group Risk Escalation process and understands complaint handling
• CAPA ownership / support
• Own Notified / Regulatory body inquiries
• Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
• Support Risk Management activities from product concept through product obsolescence.
• Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy
• Ensure verification and validation evidence supports the planned risk mitigation strategy
• Complete Document Change Request Reviews in a timely and objective manner
• Mentor engineers on risk management within the organization
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Ability to work independently with minimal supervision and coach/mentor junior or entry level engineers
• Additional duties may be identified by functional management based on the current project/business objectives including up to 10% travel.

Required Qualifications

• Bachelors degree – Life Science or engineering degree preferred to understand and interpret technical issues; Master’s preferred.
• Minimum 3 years experience, or 7+ years experience preferred in Operations Quality or Design Quality
• Experience in risk management, including a working knowledge of ISO 14971 and 62366, and TR 24971
• Working knowledge of EUMDR requirements
• 7+ years’ experience preferred
• Previous quality engineering experience and demonstrated use of quality tools/methodologies
• Knowledge of how design controls interact with risk management
• Knowledge of field monitoring processes
• Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Preferred Qualifications:

• Prior medical device experience preferred
• Experience working in a broader enterprise/cross-division business unit model
• Working understanding of FDA, GMP, and ISO 13485
• Working understanding of the following standards: ISO 22442
• Systems or clinical engineering experience
• Experience with basic statistics and/or reliability methodologies

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. 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 $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.