Supplier Engineer - Sunnyvale, CA
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems to maximize Patient Value. Each supplier engineer is responsible for ensuring their assigned Suppliers meet ISI requirements for product safety, quality, cost, delivery, and service.
Roles and Responsibilities:
This position has responsibility and authority to:
- Work with suppliers and ISI engineering for the new product introduction to complete part production qualification process (PPQP), which includes but not limited to delivering on the following deliverables: spFMEA, Special Process Validations, Process capability, MSA, capacity analysis, and FAIR.
- Lead and resolve the supply continuity/ quality issues at suppliers through in depth root cause and corrective actions utilizing SCARs, SCRs (Supplier Change requests) processes.
- Driving change to ISI specifications as necessary by understanding and changing specifications and drawings including driving the ECO process to implementation.
In order to adequately perform the responsibilities of this position the individual must possess:
- BS degree in Engineering or equivalent, Masters’ degree preferred
- Experience in a high-volume medical device company is a plus
- Minimum 5 years in an engineering role in a medical device company.
- Related experience in Supplier engineering/manufacturing operations a plus.
- Excellent knowledge of 21 CFR part 820 and ISO 13485 (experience in auditing suppliers to these standards):
- Demonstrable knowledge of a wide range of manufacturing processes including understanding of key input variables for quality, cost and capacity (specialization can be in metal fabrication, plastics, electronics, and/or contract manufacturing)
- Practical knowledge of pfmeas and process validations
- Ability to read and interpret detailed mechanical drawings and communicate technical information
- Excellent problem solving and project management skills
- Excellent written and verbal communication skills including presentations to executive level management
- Practical knowledge of part production qualification process
- Significant computer experience using Windows, Word, Excel, Minitab or equivalent
- Proven ability to motivate suppliers
United States of America
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Job Title: Supplier Engineer
Location: Sunnyvale, CA
Job Type: Temp Position
Reference ID: 318693
Posted Date: 4/30/2018