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 103,000 colleagues serve people in more than 160 countries.
Job Description Summary - Analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met
Job Description - We are seeking an experienced, high caliber Mechanical 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. Employees act on their strong desire to make a difference, partner with others and put ideas into action. Employees are engaged by a work culture that is team-oriented, fast paced and progressive.
Impact this role will have on Abbott:
- Execute and support on-time completion of Design Control Deliverables
- Support and ensures the proper prediction of, and the ultimate product performance of the electrical system
- Evaluates product design to identify potential design issues and drive technical decisions
- Able to troubleshoot and debug design issues and drive technical decisions
- Support on-time execution of Quality Plans for internal development, OEM-based, and design change projects
- Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
- Support 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 internal & external audit responses
- Support product re-certifications
- Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
- Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
- Complete Document Change Request Reviews in a timely and objective manner
- 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.
- 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.
- Performs other related duties and responsibilities, on occasion, as assigned.
Work with a variety of production and lab equipment, small hand tools, test equipment and precision measuring instrument. Also uses standard office equipment such as telephone, fax/copier and a personal computer with standard office software.
Work environment varies from well lighted office/cubicle, low to moderate noise level, production environment, labs, to a variety of conditions caused by travel requirements such as customer offices, research labs, testing labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.
Activities require a significant amount of sitting in front of a computer monitor, some standing and walking. Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment, lab equipment etc. Perform tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees. May require some lifting or moving of lab and office equipment etc.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
- Bachelor level degree in Mechanical Engineering, System Engineering, Industrial Engineering or similar; advanced degree preferred
- 0-2 years’ experience in a degree-related field
- Solid fundamental understanding of mechanics and materials
- Hands on experience with lab testing and debugging of mechanical designs using standard lab equipment
- 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
- 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 travel approximately 10%, including internationally.
- Ability to maintain regular and predictable attendance.
Your preferred qualifications and education:
- Understanding of implantable medical field
- Prior design and development experience in the related field
- Statistical method and Critical to Quality training and experience
- Root cause analysis (CAPA) experience
- Experience with Design for manufacturing, Design of Experiment, design simulation and/or modeling
- Familiarity with FDA/ ISO standards and regulations
- ASQ CQE or other professional certifications desirable