Senior Manufacturing Engineer

1 week ago

Sunnyvale, United States Intuitive Full time
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

This Senior level manufacturing engineer will support multiple manufacturing lines for both mature and new instruments and accessories for the Ion platform. This engineer must be able to support existing manufacturing lines, recommend and implement improved manufacturing processes, 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.

Essential Job Duties
  • Lead manufacturing line transfer projects, including:
    • Lead project management effectively, including monitoring schedules for multiple functions across two plants
    • Procure, assemble, and qualify custom mechanical and electromechanical equipment
    • Improve equipment documentation and design as needed for continuous improvement in preparation for further transfers
    • Develop an in-depth understanding of our manufacturing processes, and transfer knowledge to new engineers and assemblers from a remote location to facilitate an effective transfer
    • Troubleshoot electromechanical equipment problems, including collaboration with third party equipment makers as needed, e.g. braiders, laminators, or testing equipment
  • 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
    • Identify, design, qualify, 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 mentor others in manufacturing process validations, process FMEAs, and other elements associated with production Master Validation Plans
    • Provide product and process Design for Manufacturing/Assembly (DFX) input to enhance manufacturability, and lead improvement implementations
    • Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders
    • 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
  • 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
Qualifications

Required Skills and Experience
  • Strong technical problem solving and analytical skills
  • Familiar with various component manufacturing processes (machining, injection molding & MIM, stamping, coining, extrusion)
  • Expertise in mechanical CAD software (SolidWorks)
  • Expertise in Process and Equipment Qualifications (IQ/OQ/PQ/PPQ)
  • Strong organizational skills and ability to work on several fast-paced projects simultaneously
  • 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 required
  • 25% travel (including international) is required
Required Education and Training
  • Minimum B.S. degree in engineering discipline, M.S. preferred
Preferred Skills and Experience
  • Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma is a plus.


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 / Affirmative Action 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.

EEO and AA Policy

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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