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.
Senior Development Quality Engineer
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 St. Paul, MN location in the Structural Heart Team . Our products include prosthetic heart valves, occluder and devices for treatment of other structural heart defects.
As the Senior Development Quality Engineer , you'll support sustainability of commercially released products. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
What You'll Work On
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
Lead on-time completion of Quality deliverables and business initiatives.
Support the definition of objective, measurable, discrete, and verifiable customer requirements and product requirements.
Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis.
Support Test and Inspection Method development including Method Validation activities.
Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
Support manufacturing process development and qualification for design changes on Commercial products.
Support Supplier related changes for Commercial products.
Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
Support, review, and approve Document Change Order in a timely manner.
Lead, coach, and mentor junior engineers.
Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.
Build strong collaborative partnerships with cross functional teams including Program Management, Research & Development, Regulatory Affairs, Supplier Quality, Manufacturing Quality, Manufacturing Engineering and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.
Support regulatory audits as a Subject Matter Expert for Design Controls and other aspects of the quality system.
Support and ensure internal & external audit responses and on-time product re-certifications.
Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
Own Corrective Action/Preventive Action (CAPA) investigations.
Additional duties may be identified by functional management based on current project/business objectives.
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.
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.
Required Qualifications
Bachelor's degree within an Engineering field or a closely related discipline.
5-8+ years of medical device engineering experience and demonstrated use of Quality tools/methodologies.
Preferred Qualifications
Bachelor's or advanced degree in Mechanical or Biomedical Engineering
Prior experience with Cardiovascular medical devices
Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Multitasks, prioritizes, and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel occasionally (
* 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:
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.