Senior Design Assurance Quality Engineer Job
Job Description Job Attributes+
Plymouth, MN, US
40 hours per week
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 115,000 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 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.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
We are currently recruiting for a Senior Design Assurance Engineer. 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 Senior Design Assurance Engineer, you’ll have the chance to represent Design Assurance on electrophysiology catheter and disposable sustaining engineering projects. This role is responsible for maintaining a 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 review 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
- Alignment of design outputs to production and process controls
- Maintain DHF, design input / design output, external requirements, and risk management documentation
- Lead risk management meetings assessing the impact of product or supplier changes to risk profile
- Lead and execute design verification and validation activities including test planning and execution, and creation of protocols and reports
- Interpret external standards and implement product requirements and testing to meet external standards
- Ensure DHF content completion, integrity, and regulatory and standards compliance; collaboratively communicating and resolving gaps
- Lead, design, test, and inspection method development validation activities
- Lead root cause investigations, including corrective and preventive action activities, with the purpose of identifying the underlying issues and offering efficient long-term solutions.
- Present to the director level on significant matters
- Serve as a front-room representative during internal and external inspections and inquiries from regulators such as FDA and ISO as it relates to design assurance
- Ability to work both within a team, and independently, in a geographically diverse business environment
- Serves as a resource in the selection, orientation, and training of new engineers and employees
- Mentor employees by sharing technical expertise and providing feedback and guidance
- Strong verbal and written communications with effective communication at multiple levels in the organization
- 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
- Bachelor level degree in an Engineering or Science
- 5+ years’ experience in medical devices
- Strong technical writing skills
- Experience with root cause identification and problem solving
- Degree in Material Science, Mechanical, Biomedical, Electrical, or Chemical Engineering
- Engineering experience and demonstrated use of Quality tools/methodologies
- Knowledge of FDA, GMP, ISO 13485, and ISO 14971
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
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.
The base pay for this position is $71,300.00 – $142,700.00. In specific locations, the pay range may vary from the range posted.
- iso 13485
- product requirements
- design assurance
- iso 14971
- sustaining engineering
- chemical engineering
- design verification
- technical design
- test planning
- technical writing
- root cause identification
- standards compliance
- root cause investigations
- risk management
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.