Abbott Sr. Development Quality Engineer in Sunnyvale, 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, Senior Development Quality Engineer 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.

Impact this role will have on Abbott:

  • Act as Core Team Lead and ensure on-time completion of Design Control Deliverables

  • Bring additional development expertise to the product development process

  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects

  • Accountable 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

  • Exercise judgment in planning and organizing work; monitors performance and reports status

  • Build strong collaborative partnerships with Program Management and Research & Development to ensure crossfunctional customer needs are met without creating barriers to development cost, time and scope

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

  • Develop and lead other team members

  • Perform other duties and responsibilities as assigned by management

  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

  • Performs other related duties and responsibilities, on occasion, as assigned

Your experience(s), education and knowledge will further expand Abbott’s marketplace success:

  • Bachelor level degree in Mechanical/Biomedical Engineering, or similar field; Advanced degree preferred

  • 5 years’ experience in a degree-related field

  • Experience with product development (in a Development or Quality role), test method development and validation, test execution, failure analysis and risk management

  • Experience with quality systems and standards compliance

  • Excellent verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills

  • Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner

  • Advanced personal computing skills, including report writing, and familiarity with common MS Office applications

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