Primary Function of the Position Contribute your technical manufacturing, leadership, and project management skills to a dynamic manufacturing engineering team creating precision instruments for minimally invasive robotic surgery. This key technical management role will guide and mentor a talented engineering team responsible for supporting instruments product launches by designing manufacturing lines and equipment, improving manufacturing processes, creating and maintaining all associated manufacturing documentation, dispositioning discrepant material, and maintaining compliance with our quality system. Essential Job Duties Lead a team of Product Manufacturing Engineers, in collaboration with other organizations, to support production of complex products with responsibilities including but not limited to: - Provide strategic and technical leadership to the Manufacturing Engineering organization. - Ensure the professional development of individual team members. - Establish group and individual objectives, priorities, and metrics. - Manage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessary. - Lead the Manufacturing Engineering team to launch mid-volume MP instruments products. - Ensure fulfillment of product development goals. - Create, maintain, and improve “mid-volume” manufacturing assembly lines, specifying and/or refining BOMs, workflow processes, manufacturing plan, and detailed work instructions. - Analyze instrument-manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing. - Specify, design, document, build and qualify the equipment necessary to perform each process step, while providing necessary manufacturing capacity. - Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ). - Analyze the data from current Manufacturing Operations to review trends, opportunities for improvement and implement changes on a continuous basis- Ensure reliability and efficiency improvements of existing products - Provide technical support for failure analysis and root cause investigation of product failures. - Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation. - Work with Quality Engineering group to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements, and support design reviews in accordance with product development procedures. ## Qualifications Required Skills and Experience - Minimum of ten years’ engineering experience manufacturing complex electro-mechanical products. - Ability to motivate, mentor, and inspire a high-capacity technical team. - Experience developing products from early-stage concept to volume manufacturing. - Prior responsibility for validation of processes, equipment, and products. - Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and CpK. - Familiarity with mechanical CAD (Solidworks) and PLM (Agile) software - Excellent organizational skills; Able to manage multiple fast-paced projects simultaneously. - Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers. - Able to travel periodically to suppliers or Intuitive Mexicali plant Required Education and Training - Minimum B.S. degree in engineering discipline, M.S. preferred. Working Conditions - None Preferred Skills and Experience - Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment. - Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments. ## Additional Information 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: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.