Medical Device Instruments Manufacturing Engineer - Weekend

Company: Intuitive
Location: Sunnyvale
Posted on: June 19, 2022

Job Description:

Company DescriptionJob DescriptionPrimary Function of Position:
This highly skilled manufacturing engineer will support multiple manufacturing lines for both mature and new instruments, accessories, and endoscopes for the Ion platform. This engineer must be able to develop new and improved manufacturing processes, and keep existing manufacturing lines running smoothly by collaborating across functions to solve a wide variety of technical process and equipment problems. This person will work in-person Friday through Monday on a four day, 10 hours/day shift.
Roles and Responsibilities:

• Support several Ion manufacturing lines including:o Establish regular communication with the production team to ensure they have the best support possible for both short and long term needso Manage product reliability improvements from concept to implementationo Identify, design, qualify, document and introduce assembly/test fixtures and equipmento Improve process flows of Ion instrument manufacturing lines to optimize for reliability, efficiency, capacity, cost, and technician safetyo Execute and mentor others in manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Planso Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability, and lead improvement implementationso Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorderso Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementationo Provide technical support for failure analyses and root cause investigations of product failures
  • Contribute to the establishment of group and individual objectives consistent with overall product development goals, including priority setting, establishment of metrics, and effectively communicating progress
  • Provide resource budget estimates for product and process improvements, tooling development, and testing
  • Works with Quality and Regulatory to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements
    QualificationsSkill/Job Requirements:
    • B.S. degree in engineering discipline, with 5 years experience M.S. preferred with 3 years experience
    • Prior responsibility for validation/verification of processes, equipment and products
    • Strong technical analytical skills, background in material bonding, catheters, and vision-related products is a plus
    • Prior responsibility in decision making for component manufacturing processes (machining , injection molding & MIM, stamping, coining, extrusion)
    • Familiar with mechanical CAD software (SolidWorks)
    • Strong organizational skills and proven ability to work on several fast-paced projects simultaneously
    • Prior experience with managing product and process changes
    • Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials, and stress analysis is a plus
    • Able to communicate effectively and professionally with cross-functional peers, executive leadership, internal customers, and external suppliers
    • Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design is a plus
    • Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma is a plusAdditional InformationAll your information will be kept confidential according to EEO guidelines.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 : DayTravel : 10% of the timeTravel Requirements:10% of the time Shift:Day

Keywords: Intuitive, Sunnyvale , Medical Device Instruments Manufacturing Engineer - Weekend, Healthcare , Sunnyvale, California