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
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