Principal Clinical Engineer

• Serve as the subject matter expert when establishing and implementing project plans for product development including preclinical testing, bench testing, model development needs, in-vitro test methods and plans and in-vivo animal studies.
• Oversee budget spending for pre-clinical projects and to ensure appropriate resources are used for the continuous development and improvement of internal testing capabilities.
• Contribute to strategies for the clinical use of products and recommend solutions that align with Company objectives.
• Collaborate with internal and external multi-disciplinary teams, with a broad scope of discretion, to identify critical issues and communicate project advancements.
• Provide regular updates to management regarding project status, and critical issues that may affect attainment of project completion dates. Collect input and direction to revise tactical plans for projects to move forward.
• Create and execute design verification and testing plans, leading team meetings where progress is discussed, decisions are made, and updates are communicated.
• Ensure project teams are conducting 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.
• Participate in the hiring, training and performance management of assigned team aiming toward productively achieving department goals.
• Stay current on information related to high quality pre-clinical testing capabilities.

• Bachelor's degree in mechanical or biomedical engineer, or related discipline and a minimum of 12 years of related experience in the medical device or related regulated industry or equivalent combination of education and work experience
• Preferred extensive experience in a clinical/technical innovation role, with specific focus on process, GLP, HFU, and/or assessing design and usability of endovascular or neurovascular devices.
• Preferred prior experience leading technical teams through the execution of novel technologies.
• Ability to understand the intricate nuances to what is clinically meaningful to physicians who use similar type of technology.
• Ability to collaborate effectively with internal and external stakeholders at all levels to accomplish project goals, example: senior management, field experts, investors, regulatory agencies, etc.
• Deep knowledge and expertise in execution throughout the product development cycle.
• Expert knowledge of product design under ISO 13485 with ability to interpret regulations, guidelines and policy statements (QSR, MDD, and ISO), or any comparable quality systems.
• Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings.
• Excellent written and oral communication skills with technical writing capabilities.
• Ability to prioritize multiple projects independently, and influence others with proven decision making, hands-on and results-oriented work style.
• Ability to travel 15-20% of time.

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.