Description:
Leading an active lifestyle is important to the many people we serve. The Structural Heart division is a high growth business division working on MitraClip, TriClip, Valve Replacement Portfolios and novel Structural Heart therapies, allowing people to restore their health and get on with their lives.
Our locations in Menlo Park, CA or St. Paul,MN currently have an opportunity for a Contract R&D Clinical Engineer.
We are seeking an engineer with experience that will allow them to evaluate usability of devices through human factors evaluations, develop anatomical models, and perform verification and validation testing. In this role, you will interact with physicians, medical staff, and various cross-functional teams, including Marketing, R&D, Risk Management, Medical Affairs, Quality and Regulatory Affairs. Work requires the application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques.
WHAT YOU'LL DO
- Perform tasks within a larger effort such as usability testing, validation testing, model development, and technical protocol/report writing.
- Simulate or test aspects of new projects to evaluate prototypes and validate output as meeting customers' intended use requirements; analyzes data collected from the field or from research studies.
- Perform lab testing and data analysis.
- Contribute to the evaluation and validation of a specific subsystem or project as necessary to conduct feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies.
- 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.
EDUCATION AND EXPERIENCE
Required
- BS Degree in biomedical, mechanical, electrical, biological or physical science.
- Minimum of 1 years of relevant work experience in medical product development and/or a graduate degree with relevant project experience.
- Strong analytical, problem solving skills.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Strong verbal and written communication ability.
- Meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 10%, including internationally.
- Ability to maintain regular and predictable attendance.
Preferred
- Master's in biomedical, mechanical, electrical or biological or physical science or medicine.
- Advanced credential in a relevant discipline/concentration, including Biomedical Sciences
- Medical device experience
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