- Six Sigma
- FDA Regulations
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.
Working under general supervision, is responsible for providing engineering support to device manufacturing operations. Develops and implements efficient, cost-effective process improvements. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises an appropriate level of technical judgment in planning, organizing, performing and coordinating product development engineering assignments. Performs engineering studies. Stays abreast of and communicates technical advancements to colleagues and associates. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
Provides engineering support for existing operations
May perform dimensioning and tolerance evaluations of components, drawings and tooling
May perform electrical analysis of failed components or devices for troubleshooting and corrective action purposes
Oversees device configuration control and modifies the configuration as required
Writes Engineering Test Reports, memos, Engineering Change Papers, creates travelers, and develops written operator procedures
Performs process validations on equipment, test methods and/or processes as required.
Resolves and/or facilities the resolution of problems including identifying causes to prevent re-occurrence
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.
Support invention disclosures
Gain a detailed understanding of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.).
Gain a detailed understanding of the quality and regulatory requirements of Abbott, FDA and ISO regulations, managing projects within these requirements
Support pre-clinical and clinical testing of devices
Support design reviews and physician visits.
Bachelors Degree (± 16 years) Mechanical or Biomedical Engineering, or related engineering field OR an equivalent combination of education and work experience
Minimum 1 year relevant design and manufacturing work experience as related to medical devices. Experience with a wide variety of manufacturing processes and DFM preferred.
Demonstrated ability to analyze and evaluate technologically complex devices.
Experience working in a broader enterprise/cross-division business unit model preferred. 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. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 5%, including internationally.
Experience with machine tool and/or molding concepts preferred.
Experience within an operations focused environment preferred.
Solidworks or other CAD experience required. Analytical design, Design for Six Sigma, or similar tool set preferred.