Senior Development Quality Engineer

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.

     

JOB DESCRIPTION:

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.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• 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, CA location in the Structural Heart division. 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 Development Quality Engineer, you'll be responsible for ensuring that risk management is effectively implemented throughout the product life cycle.  This position provides oversight and guidance for application of Risk Management principles, ensuring that Risk Management requirements are built into the quality system processes and procedures and execution of risk management decisions and activities.  The ideal candidate has significant experience in creating new Risk Management documents and revising existing risk-related documents as part of post-production activities.

What You’ll Work On

• Product Usability/Human Factors Engineering
• Manufacturing Process Control/Inspection Planning – developing direct and indirect control points to inspect products in production and assure specifications can be met before final release
• Test Method Development/Validation
• Design Verification/Validation
• Corrective and Preventative Action (CAPA)
• May be responsible for identifying issues requiring data queries & bounding to implement complex product stops & develop release criteria.
• Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• Develops and implements Process Monitoring Systems by identifying critical process and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Creates Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, by identifying & implementing more effective tools & materials, and by communicating new tools/materials to respective teams.
• Ensure compliance to product specific standards, cGMP, QSR, US FDA, ISO, IEC, UL, EN, and MDD/MDR requirements and solid understanding of the application of ISO 13485/14971
• Perform and guide risk management activities to drive collaborative discussions on appropriate mitigation strategies. 
• Conducts special analyses and projects as required.
• Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
• Performs other related duties and responsibilities, on occasion, as assigned.
• Maintains risk documentation and establishes procedures that affect department. 

Qualifications

• Bachelor's degree in an applicable engineering discipline with 5+ plus years of progressively more responsible work experience in quality assurance and design related to medical de