Senior Manager, Instruments

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies like the da Vinci surgical system and Ion have transformed how care is delivered for millions of patients worldwide.  Were a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.  The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful because every improvement we make has the potential to change a life.  The Future Forward organization is Intuitive’s advanced concepts group. We explore emerging technologies, prototype next-generation solutions, and build software experiences that shape the future of robotic-assisted surgery.  If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.  Primary Function of Position The Senior Manager of Instruments guides the design, development, documentation, and verification of new and derivative complex flexible instruments. They will lead multiple design teams and are responsible for design, development, project schedules, product performance against requirements and the management of a multi-disciplinary group of engineers and other technical personnel to ensure efficient product development. Essential Job Duties Provide vision for technical project team and foster environment that encourages creativity, risk taking, and crisp execution Develop working knowledge of external customer needs/requirements to ensure product designs provide value to patients, physicians and hospitals Establish group objectives and individual work goals consistent with overall product development goals Assign tasks, set priorities, establish metrics, and track progress Assess employee performance and provide coaching to improve performance Manage, coach, and mentor engineers, technicians, and drafters as required Ensure design engineers follow appropriate design history file guidelines per FDA requirements and hold design reviews in accordance with product development procedures Provide engineering resources to support Process Development, Manufacturing, Supplier Engineering, Test Engineering, and Quality to facilitate transfer of designs Provide administrative leadership / control for planning, staffing, budgeting, and project/program cost tracking Build and maintain strong partnerships with cross-functional stakeholders including Product Management, Clinical Research, Clinical and Medical Affairs, Process Development, Testing, Supplier, Quality, Regulatory Affairs and Marketing to ensure alignment throughout product development and lifecycle management Serve as the primary R&D liaison to senior leadership and in cross-functional meetings, presenting technical updates, design rationale, and risk mitigation strategies Required Skills and Experience Minimum 10 years of experience designing and developing medical instruments, especially in the flexible and/or endoluminal space Minimum 5 years as a people manager, or equivalent project/team leadership, with proven ability to work well in a team environment while managing multiple projects and/or teams Hands-on engineering manager with the proven ability to work with highly technical teams Strong understanding and experience of design control, risk management and design V&V from early design and development through commercialization as described in ISO 13485, ISO 14971 and FDA Quality System Regulations Knowledge of and experience with CAD and analysis tools that drive design excellence Expertise in biocompatibility principles and regulatory requirements, e.g. ISO 10993 Knowledge of reprocessing and high-level disinfection requirements for reusable medical devices and applicable standards, e.g., ISO 17664 Experience with root cause analysis and design of experiments Strong project management, planning, and change management skills Ability to lead/influence cross functional teams in the design of complex medical systems Experience designing products in a highly regulated environment Excellent communication (written, verbal), presentation and documentation skills Strong people management abilities with capability to ensure team success (staffing, productivity) as well as career development of team members Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typica