Sr. Design Assurance 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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

Our location in St. Paul, MN or Santa Clara, CA, currently has an opportunity for a Senior Design Assurance Engineer,

The Opportunity

This position works out of our St. Paul, MN or Santa Clara, CA sites in the Abbott Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

What You'll Work On

MAIN PURPOSE OF THE ROLE

Responsible for completing Design Assurance activities in new product development from concept through commercialization. Conduct risk assessment/management and provide support to the regulatory department in

demonstrating compliance to QSR and ISO 13485 Quality System. Participate in cross-functional teams to implement design controls, validate test methods, plan verification and validation activities and provide critical quality review of protocol and report content. May support non-conformances, CAPA investigations, health hazard analysis, complaint investigations or supplier change notification activities for CSI products.

Essential Duties and Responsibilities:

• Partner with product development engineering, clinical, marketing, regulatory, and others to assure appropriate

quality requirements are defined for the specific device application and target patient population

• Lead cross functional teams in completing risk assessment and risk management activities

• Facilitate assessment and testing of biocompatibility for new and sustaining products

• Support regulatory submission content and review for compliance to QSR/MDD/MDR regulations

• Participate as member of a product development team responsible for supporting activities required to ensure

quality of the design through compliance with design controls

• Collaborate with R&D to create, optimize and validate mechanical and analytical test methods

• Support translation of user needs into design inputs and outputs.

• Work with cross functional team to plan and conduct design verification activities, human factors and design

validation activities

• Work with cross functional team to assess impact of proposed supplier changes

• Use statistical tools to analyze data and make acceptance decisions

• Provide support to Post Market Surveillance group to ensure trends are being assessed for impact to product risk

• Ensure technical accomplishments and other testing are fully documented for reference and traceability through

company systems

Required Qualifications

Education

• Bachelor or Masters of Science Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Chemical Engineering, Industrial Engineering or related technical discipline.

• Minimum 5 years of experience in medical device or pharmaceutical industry or any other regulated industry.

• Regulatory compliance awareness in 21 CFR 820, ISO 14971, ISO 13485.

• Design assurance experience in risk management and design controls.

• Technical skills and ability to provide solutions to a variety of technical problems of moderate scope and

complexity.

• Practical approach to Quality and a partnering style with colleagues in all functions in the business.

• Technical writing and presentation skills

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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.

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The base pay for this position is $72,700.00 - $145,300.00. 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.

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