Illuminant Surgical

| 💡 Company We give doctor’s superpowers. Illuminant Surgical builds precision access and visualization technologies for all clinical procedures where accuracy matters, from spine surgery to cancer biopsy. Our breakthrough platform, Skylight™ is the world’s first real-time anatomical projection system that dispays images directly on the patient to give doctors an x-ray vision view for safer surgeries. Founded by two Stanford engineers and doctor, we’re a multidisciplary team of engineers, clinicians, regulatory, and business professionals united in using our skills to make an impact on patients. We’re backed by leading venture capital firms, the National Science Foundation, the National Institute on Aging, and the National Cancer Institute. Come help us solve tough problems at the intersection of software, hardware, and clinical practice in a beautiful office in sunny Culver City, CA next to the world’s leading hospitals and care centers. You’ll be joining a team where you will make a real difference. You’ll solve problems that have likely never been solved while working alongside talented, supportive teammates who challenge and inspire you. We push the limits of innovation, but we do it with humility, humor, and a shared commitment to each other’s success. We offer comprehensive healthcare benefits, 401(k), and generous equity packages. Learn more at illuminant.ai 💼 The Role We are seeking a highly motivated Clinical Engineer to lead the development, operation, and management of a state-of-the-art bioskills laboratory. This role will focus on supporting cadaveric testing, validation of medical devices, and research initiatives that involve radiological test equipment. The successful candidate will combine engineering expertise with scientific research skills, ensuring compliance with safety and regulatory standards while also contributing to scientific documentation and grant applications. The ideal candidate is intrinsically motivated by biomechanical research and thrives in a hands-on role that requires both technical precision and practical problem-solving, whether that means working directly with cadaveric specimens, setting up complex test equipment, or troubleshooting experimental challenges. Just as importantly, they bring strong collaboration skills and excel at working across multifunctional groups, including engineers, clinicians, and researchers, to drive impactful outcomes in medical innovation. To excel in this role, you will have worked in academic or industry bioskills lab in the past and have strong scientific mindset and communication abilities. 📝 Responsibilities Bioskills Lab Management (~30% effort) Establish, organize, and maintain the bioskills lab for cadaveric and preclinical testing. Oversee daily lab operations, including scheduling, setup, and teardown of experiments. Ensure compliance with health, safety, ethical, and biosafety and radiological safety regulations. Technical & Scientific Work (~30% effort) Operate and maintain radiological and imaging equipment used in validation and testing procedures. Contribute to the design and execute experimental protocols for device evaluation Document procedures, testing outcomes, and technical validations in compliance with regulatory and scientific standards Cross-Functional Collaboration (~30% effort) Work closely with R&D, regulatory, and clinical teams to ensure alignment of testing protocols with company goals. Research & Grant Development (~10% effort) Collaborate with internal and external researchers, clinicians, and engineers to design and conduct studies. Support preparation of grant applications, including drafting technical/scientific content, experimental design, and validation data. Author and contribute to scientific reports, publications, and presentations. 🏆 Qualifications Required Must reside in Los Angeles Metropolitan Area or be willing to relocate. This is an in-person role. There is no remote option. Bachelor’s degree in life sciences and/or engineering OR trade school certification (IE, prior working experiences as a surgical technologist or related field) Deep experiences in handling and preparation cadaveric specimen Strong understanding of biosafety and ethical compliance in preclinical/cadaveric research. Excellent project management and organizational skills. Strong technical writing and documentation abilities. Collaborative mindset with ability to work cross-functionally in a fast-paced research environment. Can meet the Physical Demands: Required to sit; climb or balance; and stoop, kneel, crouch or crawl Required to regularly lift and/or move up to 20 pounds, and occasionally lift and/or move up to 100 pounds Bonus Published author in peer-authored journals Experience in using imaging devices such as fluoroscopy, mobile CT scanners, and ultrasound.

| 💡 Company We give doctor’s superpowers. Illuminant Surgical builds precision access and visualization technologies for all clinical procedures where accuracy matters, from spine surgery to cancer biopsy. Our breakthrough platform, Skylight™ is the world’s first real-time anatomical projection system that dispays images directly on the patient to give doctors an x-ray vision view for safer surgeries. Founded by two Stanford engineers and doctor, we’re a multidisciplary team of engineers, clinicians, regulatory, and business professionals united in using our skills to make an impact on patients. We’re backed by leading venture capital firms, the National Science Foundation, the National Institute on Aging, and the National Cancer Institute. Come help us solve tough problems at the intersection of software, hardware, and clinical practice in a beautiful office in sunny Culver City, CA next to the world’s leading hospitals and care centers. You’ll be joining a team where you will make a real difference. You’ll solve problems that have likely never been solved while working alongside talented, supportive teammates who challenge and inspire you. We push the limits of innovation, but we do it with humility, humor, and a shared commitment to each other’s success. We offer comprehensive healthcare benefits, 401(k), and generous equity packages. Learn more at illuminant.ai 💼 The Role We are looking for a Quality Manager to drive key quality activities for our market-defining precision access and visualization platform. This role presents the unique opportunity to see a medical device through its product life cycle from design controls to pre-market submissions and post-market monitoring. They’ll have front-row seats in seeing their direct contributions impact clinical care. Longer term, they will support ongoing quality assurance and manufacturing. This individual will be responsible for managing the Quality System. This position shall ensure compliance with FDA design control requirements and other applicable requirements and standards during the product development life cycle to support regulatory approval submission, and transfer to manufacturing, and commercial release. Our ideal candidate is intrinsically motivated to create a culture of quality that ensures the safe and effective delivery of medical technology to patients everywhere. They will have deep experience in interpreting and putting into practice guidelines set by federal and international regulatory bodies. They will have a deep understanding of 21 CFR Part 820, and ISO 13485. They must have excellent written and oral communication abilities to lead training and motivate cross-disciplinary groups to abide by quality principles. They are energized by the accelerated growth, deep autonomy, and trajectory-setting impact that comes with joining as an early employee. To excel in this role, you will have worked in quality roles at medical device companies in its design and manufacturing phases. 📝 Responsibilities Support the development of safe and effective products, including Software in Medical Devices (SiMD), by applying design assurance principles, facilitating/verifying compliance to design control requirements, and implementing risk management throughout the development life cycle. Review, prepare, and/or execute test protocols and reports and validations. Create and/or revise quality system procedures to ensure compliance or drive improvement. Oversee all aspects of quality assurance, document control, and quality control to ensure compliance with FDA QSR requirements, and plan for transition to QMSR. Conduct new employee quality system training and required training on new/revised quality system procedures and quality policy, and provide guidance/training on applicable standards. Keep abreast of applicable regulations and standards, perform and/or coordinate gap assessment of new quality system regulations/standards Establish, validate, and manage the electronic document control system, including the control of external documents. Interface with contract manufacturers and suppliers to analyze data and provide solutions for quality issues. Manage and/or conduct internal and external audits. Regularly exercises independent judgment and discretion regarding matters of significance. Prepares quality compliance status reports, trend findings, and escalates critical issues that warrant further actions. May supervise one or more individuals. Perform special projects and other duties as assigned. 🏆 Qualifications Required Must reside in Los Angeles Metropolitan Area or be willing to relocate. This is an in-person role. There is no remote option. Bachelor’s degree in life sciences and/or engineering At least five years of medical device quality experience Thorough knowledge of FDA QSR, ISO 13485, ISO 14971, and ISO 62366-1 Prior work experience with Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD) Experience supporting 510(k) and/or De Novo regulatory submissions Bonus Completed IEC 62304 Audit. Training in, or working knowledge of, Six Sigma or Lean principles ASQ or RAC Certification