Principal Clinical Engineer

Imperative Care is seeking a Principal Clinical Engineer to develop and improve its technology for treating ischemic stroke. The successful candidate will drive the development and improvement of the company's products, establish processes and best practices, and collaborate with internal and external teams to identify critical issues and communicate project advancements.

Requirements

• Bachelor's degree in mechanical or biomedical engineer, or related discipline
• Minimum of 12 years of related experience in the medical device or related regulated industry
• 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
• 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
• 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

Benefits

• Stock options
• Bonus
• Competitive salaries
• 401k plan
• Health benefits
• Generous PTO
• Parental leave program