- Job Title: Process Development Engineer
- Job Duration: Long Term Contract (With Extension Possibility)
- Location: Santa Clara, CA
- Responsibilities:
- Technical Support:
- Provide hands-on process support like troubleshooting and improvement initiatives
- Characterize existing processes for production and testing efficiency and cost-saving initiatives
- Create and approve Work Instructions, Production Records, and other process documentation
- Manage change control for updates to production documentation
- Participate in project teams to define and monitor process health metrics (KPIs)
- Partner with subject matter experts to support material and supplier qualification
- Support the development of Qualification and Validation plans
- Continuous and Process Improvement:
- Build relationships across the network to leverage best practices in production and testing excellence
- Focus on LEAN practices and Design for Quality and Manufacturability
- Quality Mindset:
- Advise on improvements and ensure controls are demonstrated through method validation
- Lead investigations for non-compliance observations like Corrective and Preventative Actions (CAPAs)
- Formal Training/Education:
- BS in relevant field
- 5-8 years in Medical Device or In Vitro Diagnostics
- Prior experience in Cartridge manufacturing, microfluidic devices, or DNA Sequencing preferred
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Process Development Engineer - Santa Clara, United States - Dawar Consulting, Inc.
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Description
Our client, a global leader in diagnostics and life sciences, is seeking a Process Development Engineer located in Santa Clara, CA.
Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K