New Product Development Engineer Catheters and Endoscopes
Posted on: September 21, 2023
Job DescriptionRoles & Responsibilities:The Design and Test
Engineer will own all aspects of the methods used for testing
device reliability, including simulated use and reprocessing. The
candidate will work closely with NPD, NPV and Clinical engineering
to establish clinically relevant methods, help establish
requirements and perform DV&V testing. A good understanding of
component design and process assembly will be required in order to
perform root cause analysis on failures and contribute to designs
and methods that can improve device safety, performance and
reliability. The candidate will work with a team of technicians and
will be responsible for all test activities including coordinating
technicians work to ensure efficient and timely testing. Lab
ownership will require exceptional organizational skills in order
to ensure supplies are adequately stocked and equipment is
regularly maintained and in proper working conditions.
Additionally, the candidate will be responsible for documenting
methods and executing training and certification of technicians to
procedures. Data analysis from test result and device builds will
be required in order to establish relationships between build data
and performance. Ability to design any necessary fixturing or tools
for test methods will be essential.
- Develop and document Clinically relevant Simulated use test
- Train and certify technicians
- Coordinate daily test activities and establish group
- Perform root casue analysis on failures and provide feedback to
NPD and NPI engineering
- Perform data analysis and establish relationships between
performance and build and log data
- Design and fabricate relevant fixturing required to execute
- Ownership of lab including equipment maintenance, lab supplies
and ancillary instruments
- Execute DV&V testing under controlled and regulated
conditions for the purpose of regulatory submission
- Present your findings to design engineering, clinical, and
manufacturing, and use this knowledge to create novel designs that
meet the needs of all stakeholders.
- Partner with design control engineer to follow all design
control SOPs and complete design control deliverables including
requirements, risk analysis and testing.
- Research and utilize knowledge of catheter component suppliers
and internal catheter prototyping to facilitate rapid early design
- Provide support for pre-clinical and clinical labs.
- Support process development engineering activities.
Keywords: Intuitive, Sunnyvale , New Product Development Engineer Catheters and Endoscopes, Engineering , Sunnyvale, California
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