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Manufacturing Engineer

Company: Intuitive
Location: Sunnyvale
Posted on: January 11, 2022

Job 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.

Primary Function of Position:

This highly skilled manufacturing engineer will support multiple manufacturing lines for both mature and new instruments and endoscopes for the Ion platform. This engineer must be able to develop new and improved manufacturing processes, keep existing manufacturing lines running smoothly, and lead manufacturing line transfers. The role requires the ability to collaborate effectively across functions ranging from Quality and Design to Manufacturing in the US and Mexico.

Roles and Responsibilities:

Support several Ion manufacturing lines including: Establish regular communication with the production team to ensure they have the best support possible for both short and long term needs
Manage product reliability improvements from concept to implementation, including recommending test fixtures
Document and introduce assembly/test fixtures and equipment
Improve process flows of Ion instrument manufacturing lines to optimize for reliability, efficiency, capacity, cost, and technician safety
Execute and report manufacturing process validations
Update process FMEAs, Manufacturing Line Specifications, and other elements associated with production Master Validation Plans
Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation
Provide technical support for failure analyses and root cause investigations of product failures

Provide US support for manufacturing line transfer projects, including creating and executing on detailed project schedules, procuring equipment, and training others on the product and process
Able to work upstream with product design engineers, and ability to recognize and voice manufacturing needs
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
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

Skill/Job Requirements: Minimum B.S. degree in engineering discipline, M.S. preferred
Prior involvement in validation/verification of processes, equipment and products
Strong technical analytical skills, background in material bonding and/or catheters is a plus
Prior responsibility involvement working with various part materials and commodities (extrusion, machining, plastic injection molding, MIM, stamping)
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 plus

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 : Shift 1 - Day
Travel : Yes, 10 % of the Time
Travel Requirements:Yes, 10 % of the Time Shift:Shift 1 - Day

Keywords: Intuitive, Sunnyvale , Manufacturing Engineer, Engineering , Sunnyvale, California

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