Clinical engineer [h1.location_city]

The Opportunity

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 heart failure devices. Clinical Engineering performs additional analyses and / or interviews to determine the requirements and constraints on the system and is accountable for resolving cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity, and creative / analytical techniques.

What You’ll Work On :

• Represent clinical engineering on heart failure 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
• Investigate and define clinical and human factors 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
• Plan and execute feasibility studies, pre-clinical testing, technology assessments, benchmarking, and concept evaluations to inform design decisions.
• Develop expertise in the scientific, technical, medical, and clinical aspects of Abbott heart failure devices and features and the disease states they adresss
• Contribute to the risk management process, including risk brainstorming, identification of Patient Harms, and severity and probability assessments
• Develop and lead clinical validation plans and activities, ensuring robust evidence for product performance and safety.
• Contribute to the evaluation and validation of a specific subsystem, system, or product prior to submission
• 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.

Required Qualifications

Preferred Qualifications