HealthCare Recruiters International ยท 3 weeks ago
Sr. Principal R&D Engineer (Endoscope Development)
HealthCare Recruiters International is seeking a Principal Endoscope Architect to lead the design and optimization of robotic endoscopes. This role involves collaborating with various stakeholders to define project requirements and ensuring compliance with medical device regulations.
Responsibilities
Leads the technical direction and development strategy for robotic endoscopes, ensuring alignment with company goals and industry standards
Defines project requirements, specifications, and timelines in collaboration with cross-functional teams including engineers, researchers, medical professionals, and regulatory specialists
Leverages engineering first principles and methods to drive the design, prototyping, and testing phases of the robotic bronchoscope
Oversees the integration with robotic systems, sensors, imaging technologies, and control algorithms to enable precise navigation and manipulation during a variety of interventional and surgical procedures
Provides technical expertise and guidance to resolve complex engineering challenges and ensure the successful execution of project milestones
Collaborates with regulatory affairs to ensure compliance with applicable medical device regulations and standards throughout the development lifecycle
Mentors and coaches junior engineers, fostering a culture of innovation, continuous learning, and professional development within the team
Communicates project progress, technical updates, and key insights to stakeholders, including senior management, investors, clinicians and external partners
Participates in conferences, industry events, and professional forums to promote thought leadership, and expand the company's network
Qualification
Required
At least 12 years in leading complex engineering projects
Expertise in single use accessories, steerable catheter or endoscope design and manufacturing
Excellent problem-solving skills, analytical thinking, and attention to detail
Ability to troubleshoot technical issues and optimize system performance
Effective leadership and communication skills
Ability to explain complex problems and solutions in plain language to multi-disciplinary, cross functional teams
Demonstrated ability to manage project budgets, resources, and timelines effectively
Focus on quality and safety
Experience transferring new products and processes to manufacturing
Advanced SolidWorks user with experience using Solidworks CAD and PDM tools
Strong understanding of regulatory standards such as IEC 60601-1 and FDA 510(k) submission process
Experience with risk management, analysis and mitigation
Prior experience working in a fast paced startup environment
Demonstrated experience with translating insights into intellectual property
BS in Mechanical Engineering, Mechatronics, Biomedical Engineering, or related field
Preferred
Hands-on experience in developing robotic platforms
MS or PhD in Mechanical Engineering, Mechatronics, Biomedical Engineering, or related field