Lead large group of engineers and scientists and manage the clinical development work for multiple projects within a function, program or therapeutic area and able to meet detailed project timeline and milestones
Plan and implement product development projects, and provide technical leadership and supervision to others
Ensure program objectives are determined and met, logistics are effectively coordinated, and budgets are adhered to. Act as cross-functional liaison to ensure designs and products are meeting customer needs and regulatory requirements.
Understands the business units products and related clinical workflows and know or able to learn about competitive product offering in different geographies
Engages with customers throughout product development cycle, defines clinical and workflow requirements for new product/feature development and represent the Voice of Customer in product development cycle, and drives the translation into new projects through clinical review and evaluation.
Lead the work with field and medical personnel to define the benchmarks for evaluating the clinical performance of these products/features.
Able to interpret data from customers, provide insights and recommendations, and assist the team to identify future product opportunities
Can drive and lead clinical design documentation such as user needs, feature definition, and design validation, and drives them to on-time and high quality completion.
Drives, Develops and directs pre-clinical evaluation protocols, data analysis, and reports
Reports significant progress and final findings of projects to management and product development staff in the company.
Simulates or tests aspects of new projects to evaluate prototypes and validate output as meeting customers27 intended use requirements; analyzes electrograms, diagnostic or programming data collected from the field or from research studies.
Provides input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.
Ability to supervise and train junior engineers on completing assigned work.
Help along the entire R&D value chain during ideation, research, product design & development to create smart and connected medical devices with intuitive workflows
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.
Bachelors Degree in biomedical, mechanical, electrical, or similar engineering field, or an equivalent combination of education and work experience
Minimum 7 yearsof progressively more responsible work experience in medical device industry or equivalent
Demonstrated ability to apply understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
Strong analytical, problem solving skills
Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees.
Ability to travel approximately 20%, including internationally.
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