jazzhr
Sr Clinical Engineer
Imperative Care
Campbell, USA
Full-time
Entry
Onsite
USD 140000-150000 yearly
Discovered 1 weeks ago
Free
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- Serve as a clinical engineering team member for product development including preclinical testing, bench testing, model development needs, in-vitro test methods and plans and in-vivo animal studies.
- Provide updates to team members and management (as needed) regarding project status, and critical issues that may affect attainment of project completion dates.
- Create and execute design verification and testing plans, participating in team meetings where progress is discussed, decisions are made, and updates are communicated.
- Ensure work effort supports pre-clinical testing of new products within the design control and applicable quality standards, and products are designed, developed, tested, manufactured and documented according to applicable global regulatory requirements.
- Support new team members or interns though product and procedure training as needed
- Ensure detailed plans are executed fully to support internal development projects with preclinical testing including bench testing, model development needs, in-vitro test methods and plans and in-vivo animal studies.
- Interact directly with clinical customers to identify customer input requirements for the system
- Plan and conduct ethnography studies
- Interact directly with commercial and marketing partners to identify gaps and potential solutions to existing customer needs
- Provide inputs to help quantify performance requirements for our products
- Work with design engineers to translate customer input requirements to design input requirements
- Drive completion of pre-clinical testing including validation testing
- Develop test models
- Create test plans, protocols, reports for all testing ensuring all documentation is aligned to company procedures and QMS
- Responsible for planning, conducting and completing lab activities including maintaining inventory, ordering materials, setting up and keeping lab areas clean
- Handle complaints and market claims as requested
- Support commercial events such as conferences by providing product demos or physician engagements
- BS in Engineering or related discipline or equivalent and 2+ years of experience with increasing responsibility in novel product or procedure development in the medical device industry or equivalent combination of education and experience
- Experience in one of the following fields: vascular/neurovascular interventions or surgical robotics
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