Abbott Senior Development Quality Engineer - Reliability in Plano, Texas
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 Senior Development Quality Engineer (Reliability) to assure new or modified products conform to quality standards and establish compliance with the quality system. The Sr. Quality Engineer will provide key technical expertise and guidance to the functional areas and serve as primary technical representative for reliability analysis. 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.
Provide technical expertise to the Reliability Laboratory
Analyzes failures, develops and implements investigative protocols to identify root causes, performs circuit analysis, performs device and component level failure analysis
Works with R & D to resolve reliability issues and monitors resulting corrective action
Reviews Product Analyses Reports, approving closure of files that meet company and regulatory requirements
Assures testing protocols are followed and are valid for desired results. Reviews documentation on reliability and qualification testing, determining if it fulfills the protocol design and meets company and regulatory standards. Trains technicians in the Reliability Laboratory
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 Design Control Deliverables
Technical review of protocols, reports and test method development and validations activities.
Generate protocols & reports, and support product testing
Create and ensure on-time execution of Quality Plans for internal product development process (PDP), OEM-based, Clinical Product Development (CPDP), and design change projects
Accountable for generation of PDP design verification test plans/reports for product/system requirements, including active cross-functional root-cause analysis investigation & resolution activities.
Support design test and inspection method development, and lead test method validation activities
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Generate essential requirements checklists & reports
Lead identification of essential outputs and generate Essential Output reports
Accountable for completion of labeling verification activities and labeling verification reports
Work with design engineering in the completion of customer/system/product requirements
Work with design engineering in the completion of product verification and validation
Complete Document Change Request Reviews in a timely and objective manner
Lead Risk Management activities from product Concept through Commercialization, including generation of risk management plans/reports, completion and maintenance of hazard analysis, FMECA’s and Cybersecurity risk assessments; including interactions with Post Market/ Supplier Quality/ Operations Quality / Customer Service and Product Performance team members
Supports Risk Management activities, including analyzing field data to support new product development, and supporting Fault Tree Analysis and Failure Mode Effects Analysis
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
Support manufacturing process development & qualification for new product commercialization and product changes
Assist in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Exercise judgment in planning and organizing work; monitor performance and reports status
Bring additional development expertise to the product development process
Build strong collaborative partnerships with Program Management and Research & Development to ensure cross functional customer needs are met without creating barriers to development cost, time and scope.
Additional duties may be identified by functional management based on the current project/business objectives.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Develop and lead other team members
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.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
Bachelor level degree in Engineering or Technical Field
5+ years’ experience in related field, medical device industry experience preferred.
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies, test method development and validation, test execution, failure analysis and risk management.
Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
Strong analytical/problem solving, negotiation, 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 (like Excel, Word, Visio, PowerPoint, Project etc.)
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 maintain regular and predictable attendance.
Ability to travel approximately 10%, including internationally
Advanced degree in Mechanical/ EE/ Biomedical Engineering or similar
Relevant Certification preferred
Experience in the implantable medical device field with experience in Design Assurance, Quality Assurance, Design controls and Risk Management
Prior design and development experience in the related field
Previous experience in failure analysis as well as seasoned judgement acquired through organization experience in the medical device industry is highly desirable
Broad cross-disciplinary and in-depth knowledge of the reliability engineering profession.
Statistical methods and Critical to Quality training and experience
Root cause analysis and Finite Element Analysis experience
Experience with Design for manufacturing, Design of Experiment and CAD tools,
Experience working in a broader enterprise/cross-division business unit model
ASQ certification a plus
Knowledge of requirements management tools like DOORS or similar
Knowledge using statistical tools like Minitab, Statgraphics, etc
Experience using risk management tools
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
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 firstname.lastname@example.org