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 115,000 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 (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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.

　　Required Qualifications

　　A 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 devices, preferably in electro-mechanical and implantable medical devices (class III and IV).

　　A minimum of 5 years’ experience of Risk Management in the Medical Device or Pharmaceutical Industry, preferably focused on complaint management and Health Hazard Assessments for on-market (or distributed) product.

　　Strategic thinking in the inter-relationship between product and user-focused risk management and device design and development.

　　Experienced in ISO, EU and FDA regulations, standards and guidance as applicable to risk management and device design.

　　Appropriate Science or Engineering Degree.

　　Excellent verbal and written communicator; clear and concise in communications with internal and external partners.

　　Desired: An advanced credential in a relevant discipline/concentration. Professional certification or designation, such as CQE, CSQE, CRE and/or CMQ/OE.

　　Ability to work in a highly matrixed and geographically diverse business environment.

　　Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

　　Ability to work effectively within a team in a fast-paced changing environment.

　　Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

　　Multi-tasks, prioritizes and meets deadlines in timely manner.

　　Apply Now (https://www.jobs.abbott/us/en)

　　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 (http://www.abbottbenefits.com/pages/candidate.aspx)

　　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.

　　An Equal Opportunity Employer

　　Abbot welcomes and encourages diversity in our workforce.

　　We provide reasonable accommodation to qualified individuals with disabilities.

　　To request accommodation, please call 224-667-4913 or email [email protected]