Process Development Engineer at The Fountain Group
Santa Clara, CA
About the Job
The Fountain Group is currently seeking a Process Development Engineer for a prominent client of ours. This position is located in Santa Clara, CA. Details for the position are as follows:
Pay Range: $53-63/hr
Contract: 1 year with possible extension or conversion
100% onsite
Job Description:
- Provide hands-on process support including troubleshooting and improvement initiatives.
- Support effort to characterize existing processes for production and testing - time, Overall Equipment Effectiveness (OEE), optimization and cost saving initiatives.
- Maintain processes utilized for production and testing to ensure process maps are up to date and process risk documents are updated to represent current controls.
- Partner with functional subject matter experts to support material qualification, supplier qualification, and actively manage issues found with incoming materials.
- Actively seek opportunities to optimize process performance leveraging key performance indicators and lead important strategic process improvement projects to drive down costs and improve product quality.
- Evaluate, advise, and ensure compliance for quality testing methods to optimize time, cost, and effort needed to execute necessary methods - advise on improvements and ensure controls are demonstrated through completion of method validation, spreadsheet validation, or computer system validation. Support or lead investigations for identified non-compliance observations (for example, Corrective and Preventative Actions (CAPAs) and Non-Conformance Reports (NCRs)) and provide technical input as needed to remediate discrepancies.
Qualifications:
- Bachelor's degree required
- 5+ years of process engineering experience within medical device or IVD environment
If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at 813-356-0199.
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate hired.