Sr. Manager, Design Assurance

2 days ago

Plymouth, United States Abbott Laboratories Full time

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 family, be your true self and live a full life. Youâll 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 bachelorâs 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.

The Opportunity

This position works out of our Plymouth, MN location in the EP division.

In Abbottâs Electrophysiology (EP) business, weâre 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 Sr. Manager, Design Assurance, you'll have the chance to be responsible for leading, developing, and maintaining design controls methodologies and providing quality subject matter expertise for disposable products within the Abbott EP portfolio. This positions collaborates with product development and quality engineering to support both new and current products.

What Youâll Work On

  • Provide Quality leadership in direct support of medical device development, including: Management and development of Quality Engineers and Technicians.
  • Utilize proficiency in statistical methods for design characterization, process control, reliability analysis, and design verification to drive enhanced organization efficiency.
  • Provide influential peer leadership with development partners to drive proactive quality improvements.
  • Provide technical and strategic expertise for submissions, audits, and regulatory inquiries.
  • Define and implement critical parameter for design control and related systems throughout the product lines.
  • Guides engineering team in data interpretation, conducting hypothesis testing, and applying statistical tools (e.g., Minitab, JMP) to ensure product quality.
  • Provides leadership and mentorship to enhance team membersâ technical and soft skills. Foster a collaborative environment that encourages growth and innovation within both the Quality and Development organizations.
  • Identifies opportunities to more efficiently achieve compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
  • Provide proactive, diligent, and fact-based communication to Sr. Management team, peers and team.
  • Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.

 Required Qualifications

  • Bachelors Degree (± 16 years) related field or an equivalent combination of education and work experience.
  • Minimum 5 years in engineering desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment.

  • Industry certification preferred.

  • Demonstrated and impactful experience in design control, test method validation, risk management and related industry product standards. 

  • Demonstrated and impactful strong project management and people leadership skills required.  Experience working in a broader enterprise/cross division business unit model preferred. Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Apply Now

* 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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.



The base pay for this position is $125,300.00 â $250,700.00. In specific locations, the pay range may vary from the range posted.

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