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 103,000 colleagues serve people in more than 160 countries.
This is an exciting time to join our Structural Heart division in Menlo Park. This site is growing quickly due to the success of our life-saving MitraClip medical device. The Quality Engineer will work directly with a cross functional design and development engineering team to provide Design Controls support for the next generation of MitraClip. Quality Engineers supporting new product development have the opportunity to influence product quality and program success through execution proof of concept testing, support and execution Verification and Validation, performing Risk Management, and execution of Test Method Development and Validation activities.
- Initiate, execute, and track role appropriate Design Controls quality deliverables
- Plan and execute Product Quality Risk Management activities with the cross functional development team (Failure Modes Effects Analysis, Risk Controls/Mitigations, Verification and Validation, etc)
- Develop and Validate test methods for evaluation of product requirements
- Develop and implement product and process inspection and monitoring requirements
- Collaborate and provide guidance to cross functional R&D and Manufacturing teams to establish verification and validation strategy
- Author and execute Design Verification, Shelf Life, and Process Validation studies protocols and reports
- Investigate and prove guidance and input in resolving deviations and non-conformances associated with Design Verification, Shelf Life, and Process Validation studies
- Perform and interpret appropriate data and statistical analysis of test results
- EU MDR Experience preferred
Bachelor's degree plus 2-5 years of related work experience with a good understanding of specified functional area, or Master's degree with 0-2 years of related work experience, or an equivalent combination of education and work experience.
(Technical/Business Knowledge (Job Skills)) Working technical knowledge and application of concepts, practices and procedures. General understanding of business unit/group function. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
(Cognitive Skills) Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environmen