At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world in nutrition, diagnostics, medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life.
Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Please note that candidates need to be eligible to work in the
JOB DESCRIPTION : Job Description :
Job Description :
Provide Risk Management / Quality Engineering support to product development teams, helping to ensure development of highest quality new products.
Develops quality procedures to address Risk Management requirements for new and existing products. Provides specific direction and support to address Risk Management requirements for active medical devices including programmable medical devices.
Develops and implements product risk assessments for new products, or provides coaching and mentoring to product development team members to create risk assessments.
Provides engineering support to operations engineering staff to remediate or update legacy product risk assessments. May be responsible for developing Fault Tree Analysis for new or legacy products.
Identifies and implements appropriate risk tools to facilitate identification and mitigation of product risks by applying body of knowledge / expertise and communicating to respective teams Provides formal training to new product development teams and operations staff regarding risk management processes, tools, and techniques.
Provides direction and guidance to develop and implement quality management system procedures for risk management of active devices including programmable devices.
Provides direction and guidance to develop and implement quality management system procedures for cyber security of active devices.
Utilizes knowledge and experience of medical device design, manufacturing, and usage to help identify and mitigate device risks.
Utilizes knowledge of Human Factors Engineering tools and techniques to identify and mitigate potential use errors.
Accountability / Scope
Influence / Leadership) Establishes and cultivates an extensive network of support to facilitate completion of assignments.
Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.
May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions.
Decision Making / Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
Education / Experience
Bachelor's degree plus 5-7 years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
Advanced degree preferred.
Technical / Business Knowledge (Job Skills)) Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies / relationships.
Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Has a sound knowledge of various technical alternatives and their impact.
OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL.
JOB FAMILY : Operations Quality
DIVISION : AVD Vascular
LOCATION : United States >
United States >
Temecula : Building E - TE Floor-4
ADDITIONAL LOCATIONS : WORK SHIFT :
WORK SHIFT : Standard
TRAVEL : Yes, 10 % of the Time
MEDICAL SURVEILLANCE : SIGNIFICANT WORK ACTIVITIES :
SIGNIFICANT WORK ACTIVITIES :
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities / Women / Individuals with Disabilities / Protected : :