Abbott Mechanical 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 Mechanical Engineer II to use multidisciplinary engineering knowledge to lead and contribute to a team designing and developing innovative mechanical and electro-mechanical medical devices or components/subsystems in support of company’s strategic plan. This engineer will be expected to apply their analytical and practical engineering principles in analyzing mechanical systems, overseeing the designing and running of tests, improving or fixing product features, and documenting findings. This individual should bring a level of enthusiasm, positive outlook, and inquisitiveness as they participate on cross-functional teams to resolve technical problems. The incumbent should have an affinity to learn and grow as they collaborate and support cross-functional team members from a wide range of Abbott departments in multiple geographic locations, as well as with suppliers and customers.
The duties and responsibilities for this position include, but are not limited to, the following:
Ability to make critical judgments and decisions
Provide leadership of engineering projects
Design sub-assemblies to meet broad design goals
Establish requirements and specifications
Work with physicians and other medical personnel to obtain feedback on concepts
Use empirical, numerical and experimental analysis to analyze designs
Identify and mitigate sub-assembly risks
Perform Tolerance Analyses of complex assemblies
Define test methods and conduct testing of complex mechanical and electro-mechanical assemblies
Support our intellectual property portfolio through generation and support of novel ideas and concepts
Work with internal departments and external vendors to obtain prototype parts and to understand their capabilities and limitations
Support pre-clinical and clinical testing of devices
Responsible for conducting Design Reviews at various development stages
Strong verbal and written communication skills with ability to effectively communicate at multiple levels in the orgaization
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 SJM, FDA and ISO regulations, manage project within these requirements
Gain a detailed understanding of overall schedule, manage time and task within schedule
·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.
Experience and Education:
Bachelor’s degree in Mechanical Engineering or similar discipline, 3+ years engineering experience in the Research and Development function in the Medical Device industry
Proven ability to lead projects from inception to commercialization
Experience translating customer needs into requirements
Experience with Solidworks and/or other CAD modeling software
Knowledge of medical device product development (ISO, GMP, FDA, CE) and design controls
Ability to travel approximately 10%, including internationally
Preferred Qualifications and Education:
Experience designing and testing medical devices preferred
Exposure to a variety of manufacturing processes and designing for manufacturability preferred
Experience working in a broader enterprise/cross-division business unit model preferred.
Applied experience within at least one of the following areas preferred: FEA, CFD, simulation/analytics, motion control, data acquisition.
Familiarity with dimensioning and tolerancing standard ASME Y14.5M – 1994
Exposure to a range of engineering areas that include electrical, polymeric materials, biology is desirable
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 email@example.com