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

Working at Abbott

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

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.