Abbott Sr. Clinical Engineer 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 Engineer to support product development efforts by performing clinical engineering tasks such as investigating, defining, analyzing, documenting, and testing activities associated with the development of specific products. Clinical Engineering performs additional analysis and/or interviews to determine the requirements and constraints on the assigned portion of the system and is accountable for resolving cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques.
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 internally and externally to take action and accomplish goals.
The Senior Engineer will:
Represent clinical engineering on neuromodulation product development projects. Support product development efforts by performing clinical engineering tasks such as defining, investigating, analyzing, testing, and documenting activities associated with development of specific products
Leverage clinical and product expertise to aid new concept and product development, define preferred embodiments of products, features, and algorithms, and evaluate compatibility of system components in clinical workflow scenarios
Lead/own pre-defined tasks within a larger effort such as definition, development, or validation of a system or sub-system, and drive them to on-time, high quality completion
Investigate and define clinical requirements for new devices and system features, drive integration of features into the existing clinical workflows, and facilitate the transition of these features into products through clinical review and evaluation
Interact with project teams and functional groups to plan and execute feasibility studies, preclinical studies, data development and claims studies, technology assessments, concept studies, or benchmarking studies
Develop expertise in the scientific, technical, medical, and clinical aspects of Abbott neuromodulation devices and features and the disease states they aim to treat
Provide input to the risk management process, including risk brainstorming, identification of Adverse Health Outcomes, and severity and probability assessments
Develop clinical validation plans and lead the execution of the clinical validation activities
Contribute to the evaluation and validation of a specific subsystem, system, or product prior to submission
Direct generation of Clinical Evaluation Reports
Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Perform other related duties and responsibilities, on occasion, as assigned
Four year degree in a technical field, preferably mechanical, chemical, biomedical, or electrical engineering, materials science, biochemistry, chemistry or physics or a medical field or equivalent experience
Minimum of five (5) years’ experience in medical device development and/or other highly regulated industry
Demonstrated ability to apply an expert understanding of clinical applications to issues in order to bring tasks to resolution within assigned projects
Ability to work in a highly matrixed and geographically diverse business environment
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
Ability to work effectively within a team in a fast paced environment
Strong verbal and written communication skills with ability to effectively communicate with multiple levels in the organization
Multi-tasks, prioritizes, and meets deadlines in timely manner
Ability to travel approximately 10%, including international
Your preferred qualifications and education:
Advanced degree in a technical or medical field is preferred
Prior technical or medical experience in neuromodulation
Advanced credentials in a relevant discipline/concentration, including Biomedical Engineering, preferred
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