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Manager NPI Manufacturing Engineering

Company: Intuitive
Location: Sunnyvale
Posted on: August 5, 2022

Job Description:

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 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 NPI instrument projects 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. Roles and Responsibilities:

  • 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:
  • Establish group and individual objectives, priorities, and metrics
  • Ensure fulfillment of product development goals
  • Ensure the professional development of individual team members
  • Ensure production of products meets expected output
  • Ensure quality requirements are fulfilled and maintained
  • Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation thru Agile
  • Provide technical support for failure analysis and root cause investigation of product failures
  • Plan, budget and staff projects, tracking performance throughout
  • Manage and allocate team resources over multiple projects. Provide and solicit resources to and from other teams as necessary
  • Work with Quality 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
  • Improve product quality, yields, and reduce cost
  • Improve the manufacturing process as needed
  • Complete cost analysis and lead cost reduction efforts
  • Mentor and train new employees
  • 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.
  • Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
  • Provide production line support for day-to-day engineering issues on core instrument lines
  • Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
  • Provide technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
  • Other related duties Qualifications Skill/Job Requirements:
    • Minimum B.S. degree in engineering discipline, M.S. preferred.
    • Successful experience leading projects
    • Minimum of five 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.
    • Mechanical design and analysis expertise desired.
    • 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.
    • Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments is a plus
    • Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred
    • Able to travel periodically to suppliers or Intuitive Mexicali plant 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. Shift : Day Travel : 10% of the timeTravel Requirements:10% of the time Shift:Day

Keywords: Intuitive, Sunnyvale , Manager NPI Manufacturing Engineering, Executive , Sunnyvale, California

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