Principal Clinical Engineer

Principal Clinical Engineer

Campbell, California – on-site & full-time.

Imperative Care is developing novel robotic‑assisted technologies and interventional capabilities to transform the treatment of ischemic stroke. The Principal Clinical Engineer will lead the design, development, validation, and clinical integration of our products, ensuring they meet user needs and regulatory standards.

• Serve as subject‑matter expert in product development, overseeing preclinical testing, bench testing, model development, in‑vitro methods, and in‑vivo animal studies.
• Manage pre‑clinical budgets and allocate resources to enhance testing capabilities.
• Contribute strategic recommendations for clinical use of products that align with company objectives.
• Collaborate with multidisciplinary teams to identify critical issues and communicate progress.
• Provide regular status updates to management and revise tactical plans as needed.
• Create and execute design verification and testing plans; lead team meetings to drive decisions and communications.
• Ensure all pre‑clinical testing complies with design control, quality standards, and global regulatory requirements.
• Participate in hiring, training, and performance management of the technical team.
• Remain current on advances in high‑quality pre‑clinical testing capabilities.

• Bachelor's degree in mechanical or biomedical engineering, or related discipline, and a minimum of 12 years of experience in the medical device or regulated industry.
• Extensive experience in a clinical/technical innovation role, focused on process, GLP, HFU, and the design and usability of endovascular or neurovascular devices.
• Prior leadership of technical teams through the deployment of novel technologies.
• Deep understanding of clinical relevance to physicians using similar technologies.
• Ability to collaborate effectively with internal and external stakeholders, including senior management, field experts, investors, and regulatory agencies.
• Comprehensive knowledge of ISO 13485 product design, regulatory interpretation (QSR, MDD, ISO), and comparable quality systems.
• Experience with MDRs, IDEs, PMAs, and 510(k) filings.
• Excellent written and oral communication, with technical writing skills.
• Strong decision‑making and independent project prioritization skills.
• Willingness to travel 15‑20% of the time.

Stake in company success with stock options, bonus, competitive salaries, a 401(k) plan, health benefits, generous PTO, a parental leave program, and emotional health resources.

Salary Range: $188,000 – $220,000 annually.