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.

Development Quality Engineer II

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

Structural Heart Business Mission: 

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

We are seeking a high caliber Development Quality Engineer II. A development quality engineer assures new or iterative products conform to requirements and establish compliance with the quality system. 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.  Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

What You’ll Work On

Execute on-time completion of design control deliverables

Design verification and validation test planning

Design verification and validation test protocols, execution and reports

Design input output trace matrix

Design History File organization

Customer, system, and product requirement review

Regulatory responses and submissions

Risk/hazard analysis and risk management plan/reports

Design specification reviews

Quality plans

Design change plan/reports

Investigate internal and external audit findings and write responses

Corrective and preventive action resolution

Complete document change requests

Ability to work independently with minimal/no supervision

Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps

Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments

Maintain 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

Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including up to 10% travel and regular predictable attendance

Required Qualifications

Bachelor level degree in an Engineering Discipline or other Technical Field

0-2 years’ experience in Quality or R&D role

Solid communication and interpersonal skills

Strong verbal communications and written communications with ability to effectively communicate at multiple levels in the Organization

Advanced computer skills, including report writing skills

Ability to work within a team and as an individual contributor in a fast-paced, changing environment

Multitasks, prioritizes, and meets deadlines in timely manner

Strong organizational and follow-up skills, as well as attention to detail

Preferred Qualifications

Degree in Mechanical, or Biomedical Engineering

Previous Quality engineering experience and demonstrated use of Quality tools/methodologies, statistical/data analysis

Prior medical device experience preferred

Working knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485

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

The base pay for this position is $60,000.00 – $120,000.00. In specific locations, the pay range may vary from the range posted.