Abbott Senior Clinical Engineer in Menlo Park, 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.
Job Summary :
Support product development efforts as a key member of program teams by leading systems engineering tasks defining, developing or validating a smaller program or several features on a major program.
Job Duties :
• Gathers, understands, and analyzes input requirements from stakeholders for new medical devices while supporting the instrumentation/service infrastructure. Translates information into specific system features.
• Synthesizes all gathered information together with technical and regulatory constraints in order to define a system and its behavior resulting in defining a system specification.
• Assists in determining clinical priorities for new products.
• Performs technical planning and performance evaluation studies, conducts technology assessment activities, analyzes system integration issues, generates initial baseline interface specifications, estimates costs and risk, and evaluates customer satisfaction through testing (alpha and beta), analysis and studies.
• Assign projects to specific teams and determine how systems will be architected and implemented. Provides guidance and leadership to teams as appropriate.
• Evaluates prototypes formally and informally through structured and ad hoc testing. Test aspects of new projects or algorithms to evaluate prototypes and validate output to meet intended use requirements.
• Provides input into the development of clinical system validation plans and the conduct of those tests.
• Identifies and resolves issues, escalating as appropriate.
• 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
• Bachelor of Science in Biomedical Engineering, Electrical Engineering, a related engineering field, or equivalent, including relevant coursework and/or work experience in product development.
• Minimum of 6 years of relevant, progressively more responsible work experience in medical product development and/or a graduate degree with relevant project experience.
• Demonstrated ability to apply an expert understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
• Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs required.
• Medical device industry experience preferred.
• Advanced credential in a relevant discipline/concentration, including Biomedical Engineering, preferred.
• Professional certification or designation preferred.
• Training and experience in manufacturing processes and methods preferred.
• 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.
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