Sr Clinical Engineer

• 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
• Demonstrated ability to take initiative to start projects create and meet deadlines.
• Demonstrated success working with cross functional teams and customers (physicians and hospital staff)
• Previous involvement in at least one full product development cycle
• Knowledge of and exposure to product testing and data collection
• Experience working under quality systems designed to meet governmental regulations such as FDA QSR ISO 13485 and the MDD
• Strong working knowledge of relevant regulatory standards that apply to the specific product/project
• Familiarity with Design control procedures and requirements
• Excellent communication skills (both written and verbal)
• Ability to work independently or in a team setting required and ability to travel as required for the role;

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.