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 107,000 colleagues serve people in more than 160 countries
ABOUT ABBOTT DIAGNOSTICS:
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health. Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in Santa Clara, California currently has an opportunity for a Senior Engineer, Risk Management.
WHAT YOU'LL DO
- Translates requirements into new solutions - Develops requirements and specifications for new and existing engineering designs.
- Provides input to product requirements and translates product requirements into component or Subsystem Specifications.
- Design - Leads and proposes engineering designs.
- Leads engineering design reviews with CFT and recommends improvements.
- Responsible for subsystem design, ensures design solutions are optimized and addresses requirements.
- Develops Simulations & Prototypes - Develops simulations or prototypes for new / modified subsystem or system designs and performs engineering analysis and testing.
- Implements the design of new products and/or product improvements.
- Verifies Solution - Responsible for protocol development and verification of subsystem or system designs.
- Documenting and Manging Change - Justifies changes, quality and regulatory information, and manufacturing readiness information.
- Completes change documentation to include technical rationale and formal verification test results.
- Anticipates and/or Develops/Applies Risk Mitigation - Evaluates engineering technical risks and identifies alternatives,makes recommendations and takes appropriate actions.
- Integrates inputs and assists in the development and review of risk management documentation including FMEAs,hazards and modes of control.
- Ensures quality through design Techniques and Design Alternatives - Leads and participates in Engineering Design Reviews utilizing Engineering Procedures and Engineering Tools,makes recommendations and identifies design alternatives.
- Maintains adherence to the Quality System - Implements and maintains the effectiveness of the quality system. Follows functional area policies and procedures.
- Obtains Customer Feedback for new and/or Improve Products
- Selects,builds and maintain Third Party Manufacturer (TPM) product and partner relationship
- Strategic Orientation - Ensures plans are focused on site and division priorities.
- Works with cross functional team in collaborative environment.
- Leads and Mentors - Trains and mentors associate engineers and engineers in design tools and processes.
EDUCATION AND EXPERIENCE YOU'LL BRING
- Bachelor's degree in an engineering or closely related discipline.
- 4 years progressive work experience with degree or sufficient transferable experience to demonstrate functional equivalence to a degree.
- Medical device or IVD industry experience strongly desired; moderate knowledge of external regulations and standards affecting IVDs and biologics.
- In depth knowledge and understanding of product / customer requirements.
Risk Management experience in a regulated industry (Medical and/or Defense)
Basic Statistical knowledge
Experience with DOORS
Experienced in Failure mode and effects analysis (FMEA)
Experience with requirements tracing
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with on-boarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully:
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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