Process Development Engineer

Our client, a world leader in diagnostics and life sciences, is looking Process Development Engineer. Kindly have a look at the details below and let us know if you are interested.

Job Title: Process Development Engineer

Job Duration: Long Term Contract(Possibility Of Extension)

Location: Santa Clara, CA

Company Benefits include:

- Healthcare (Medical, Dental, & Vision)

- Paid Sick leave

- 401k (with 2% employer match)

Responsibilities:

Technical Support:

• 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
• Create and approve Work Instructions, Production Records, and other documentation for processes; Managing change control for updates to production documentation
• Maintains processes utilized for production and testing to ensure process maps are up to date and process risk documents are updated to represent current controls
• Participate in project teams to define and monitor process health metrics (KPIs, key performance indicators)
• Partner with functional subject matter experts to support material qualification, supplier qualification, and actively manage issues found with incoming materials
• Support development of Qualification and Validation plans and take an active role in protocol executions

Continuous and Process Improvement:

• Optimize process performance leveraging key performance indicators and lead important
  strategic process improvement projects to drive down costs and improve product quality
• Partner across the network to build relationships with the goal of leveraging best practices in production and testing excellence (i.e. LEAN practices and Design for Quality and Manufacturability)
• Assess and provide technical input on continuous improvement initiatives and inventory optimization

Quality Mindset:

• 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
• Ensure continuous monitoring for processes per quality system requirements to demonstrate ongoing compliance
• 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
• Support regulatory inspections and audits by providing technical expertise and documentation as needed

Formal Training/Education:

• 5-8 years in Medical Device or In Vitro Diagnostics
• BS in relevant field.
• Prior experience: Cartridge manufacturing, microfluidic devices or DNA Sequencing is

If interested, please share your update resume at /