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Sr. NPI Manufacturing Engineer
Sr. NPI Manufacturing Engineer-November 2024
Sunnyvale
Nov 21, 2024
ABOUT INTUITIVE
Intuitive is hiring mission-oriented problem solvers who are ready to build a career at the intersection of healthcare and technology.
10,000+ employees
Technology, Engineering
VIEW COMPANY PROFILE >>
About Sr. NPI Manufacturing Engineer

  Company Description At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

  As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

  Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

  Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

  Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

  Job Description Primary Function of the Position

  The Senior NPI Manufacturing Engineer is responsible for the transformation of advanced energy products from early phase R&D to clinical manufacturing. Their focus will be on the creation of new clinical pilot lines, process development, and build readiness contributing to the exploration of novel system concepts for new applications of surgical robotics. They will be a responsible member of the Future Forward team supporting innovative technology development and long-term commercialization. They will have both the technical depth to resolve complex mechanical, material, and manufacturing design issues as well as the ability to work in an interdisciplinary team to troubleshoot and root cause higher level system issues. They must have strong technical depth in relevant areas and have a track record of successful manufacturing & process development efforts. Using their subject matter expertise, exceptional communication skills and cross-functional collaboration, they will work closely with the design team to bring advanced energy applications for novel clinical applications to fruition across our robotic surgical systems.

  They must excel in a high-energy, focused, small-team environment, be able to deal with high levels of ambiguity and have a commitment to achieving high quality products. A strong sense of shared responsibility and shared reward is required.

  Responsibilities

  Assess manufacturability of current designs and identify critical steps for further process developmentDefine pilot manufacturing lines for system components, instruments, and accessories, order equipment, and bring up the lineDevelop NPI strategy for supporting verification and validation of productManage suppliers and vendors to produce components, assemblies, and/or prototypesBuild and maintain top level assemblies in Agile document control systemDesign, specify, purchase, build, and qualify aids and test equipment for the line as necessaryManage completion of all manufacturing documentation in support of clinical studies or launchSupport the design team with product development activity including, but not limited to, component development, design investigations, component/product testing, and concept development.Support the design team with builds for prototypes or pre-clinical studies as requiredHands-on assembly and testing of equipment and devices to support proof of concept, design development, pre-clinical and V&V activitiesPerform tests, critically analyze results, and make design changes or recommendations to the design team Investigate and determine root cause of emerging design, manufacturing, or material defectsDevelopment and documentation of design and manufacturing documentation including inspection procedures, assembly instructions, test methods, purchase specifications, BOMs, part and assembly drawings using appropriate change control proceduresEstablish individual goals consistent with overall project goals OTHER

  Keeps the organization’s vision and values at the forefront of decision making and actionPerforms other duties as required to support the company's overall strategy and goals  

  Qualifications Preferred Qualifications

  Minimum education: BS or MS in Mechanical Engineering or related engineering or scientific discipline, or equivalent work experienceMinimum of 8 years of relevant experience, minimum 6 years with a mastersMinimum years’ experience, at least 5 years in medical device manufacturingDemonstrated ability to work in cross-functional teams with an ability to leverage internal and external resources to complete tasksExperience with validation/verification/qualification of processes, equipment, fixture, tooling, and productsPrior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design (FDA QSR 21 CFR Part 820, ISO 13485, ISO 14971, and other related external standards).Experience with 60601 and related electrical safety and EMC standards are a strong plusKnowledge of capital equipment manufacturing processes, tools, and equipment; knowledge of power systems and components desirableExperience with sheet metal fabrication and mechanical assemblies and fittings.Quantitative process development skills including (p)FMEA, Tolerance Analysis, DoE, SPC, GR&R, Hypothesis Testing, and Capability AnalysesFamiliarity with mechanical CAD (Solidworks), ERP (SAP), PLM (Agile), and ALM (Polarion) softwareStrong organizational skills and proven ability to work on multiple fast-paced project threads simultaneouslyClear and efficient documentation skills 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 Employment 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.

  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 salary ranges are listed.

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