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. 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.

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.

The Staff Continuous Improvement Quality Engineer within the EP Division of Abbott supports manufacturing and design teams by using process improvement tactics such as lean manufacturing, six sigma, DFX, or Kaizen to produce high quality products and enhance productivity. This position will be expected to be an expert on medical device process validation methodologies, regulatory expectations, and the be able to coach and direct project teams through successful and robust process validation. They will also aid in the design, development, and improvement of manufacturing processes, tooling and fixtures across the EP Division manufacturing network.

What You’ll Work On

• Provide leadership to engineering staff regarding process validations and continuous improvement activities. Mentor engineers in the proper methods of process validation including installation qualification (IQ), operational qualification (OQ) and process qualification (PQ).
• Use industry standard methodologies (lean, six sigma, DFX, etc.) to drive efficiency improvement across the manufacturing network.
• Monitor, assess, and improve in-process production, inspection, and assembly performance to ensure customer requirements are maintained, and process/business performance metrics meet goals.
• Determine and drive operations focused improvement effort based on data analysis.
• Oversee implementation of countermeasures and corrective/preventive actions in support of operations process improvements.
• Support continuing production, process development and new product introductions.
• Participate in cross-functional teams.
• Review and approve protocol and written reports.
• Drive continuous improvement of engineering technical capabilities.
• Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis.
• Coach, manage and develop technical staff.
• Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, GMP and all other applicable agency regulations.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Minimum of 8 years experience in manufacturing/process development leading and supporting continuous improvement programs within medical device manufacturing.

• Experience conducting and leading process validation activities in medical device manufacturing.

• Experience with statistical techniques (e.g., DOE, SPC).

• Experience with Lean manufacturing techniques, value stream mapping, and continuous improvement methodologies.

• Solid communication skills.

• Solid knowledge of GMP, ISO regulations.

• Demonstrated success in leading mfg technology transfer project to global operations.

• Ability to work in a highly matrixed and geographically diverse business environment.

• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.

• Ability to work effectively within a team in a fast-paced changing environment.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Multi-tasks, prioritizes and meets deadlines in timely manner.

• Strong organizational, planning, and follow-up skills and ability to hold others accountable.

• Ability to travel approximately, including internationally.

Preferred Qualifications

• Medical device experience with bioprosthetic heart valve tissue development or manufacturing or other implantable device development strongly preferred.

• Previous Development Quality Engineering experience.

• ASQ CQE or other certifications.

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 $95,000.00 – $190,000.00. In specific locations, the pay range may vary from the range posted.

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