Design Assurance Engineer I

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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.

The Opportunity

This position works out of our Plymouth, MN location in the Electrophysiology division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As the Design Assurance Engineer I, you'll support Design Assurance efforts for Novel Product Development and Sustaining Engineering on catheter and disposable projects in the electrophysiology business. This role will participate in strong collaborative partnership with cross-functional engineering teams to ensure that devices are developed and maintained in accordance with product requirements, and that they meet their intended use delivering the safest experience possible to our patients. This role will participate in reviews of requirements, specifications, and technical design documents to provide timely feedback aimed at improving product quality, safety, reliability, and manufacturability to sustaining engineering teams.

What You'll Work On

• Execute on Holistic & Strategic Design Verification/Validation Strategies with emphasis on:
  • Technical analysis of requirements, specifications, and control strategy
  • Efficient and cost-effective execution of validation and verification
• Support design, test, inspection method development, and lead method validation activities
• Participate in root cause investigations, including corrective and preventive action activities, with the purpose of identifying the underlying issues and offering efficient long-term solutions.
• Maintain DHF, design input / design output, external requirements, and risk management documentation
• Participate in risk management meetings assessing the impact of product or supplier changes to risk profile
• Participate in design verification and validation activities including test planning and execution, and creation of protocols and reports
• Review external standards and support implementation of product requirements and testing to meet external standards
• Review DHF content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps
• Present to the engineer level on matters
• Assist in pulling content as back-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance
• Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including 10% travel, including international travel and regular predictable attendance

Required Qualifications

• Bachelor level degree in an Engineering or Science
• 0 - 3 years' experience
• Strong technical writing skills

Preferred Qualifications

• Degree in Material Science, Mechanical, Biomedical, Electrical

Apply Now

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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 $50,000.00 - $100,000.00. In specific locations, the pay range may vary from the range posted.