Abbott Development Quality Engineer II in Pleasanton, California

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

We are seeking an experienced, high caliber Development Quality Engineer II to assure new or modified products conform to quality standards and establish compliance with the quality system. 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.

RESPONSIBILITIES

• Assist on-time completion of Design Control Deliverables

• Execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects

• Support for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities

• Lead Risk Management activities from product Concept through Commercialization

• Support design test and inspection method development, and lead method validation activities

• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

• Support manufacturing process development & qualification for new product commercialization and product changes

• Support and ensure internal & external audit responses

• Support and ensure on-time product re-certifications

• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements

• Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications

• Complete Document Change Request Reviews in a timely and objective manner

• Support all Company initiatives as identified by 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

Basic Qualifications:

  • Completed Bachelor’s degree in Engineering or Technical Field

  • Minimum 2 or more years of experience in Quality engineering

  • Prior design and development experience

Preferred Qualifications:

  • Advanced degree in Mechanical or Biomedical Engineering

  • Experience in the implantable medical device field with experience in Design Assurance, Quality Assurance, Design controls and Risk Management

  • Previous experience and demonstrated use of Quality tools/methodologies, test method development and validation, test execution, failure analysis and risk management

  • Familiar with the following standards/regulations: IEC/EN 60601-1 plus applicable collateral standards (‘601-1-2, ‘601-1-11, ‘601-1-6), ISO 14708-1 and ISO 14708-3, EN 45502-1, ISO 13485, ISO 14971, 21 CFR 820, Directive 90/385/EEC, Directive 93/42/EEC, Regulation (EU) 2017/745

  • Root cause analysis and Finite Element Analysis experience

  • Ability to travel approximately 10%, including internationally

  • Knowledge of requirements management tools like DOORS or similar

  • Knowledge using statistical tools like Minitab, JMP, etc

Experience using risk management tools

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com