Process Development Engineer

Santa Clara, California

Estuate Inc.
Job Expired - Click here to search for similar jobs

Job Title: Process Development Engineer

Location: Santa Clara, CA,

Contract 12 Months

Onsite Position

Relevant Experience: 5-8 years in Medical Device or In Virtro Diagnostics

Education: BS in relevant field.

Prior Experience: Cartridge manufacturing, microfluidic devices or DNA Sequencing is preferred.

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:

  • 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
  • Partner across the client 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:

  • Partnering with MSAT colleagues and Operations Quality Stakeholders to maintain the qualified state of existing processes
  • 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
  • Other duties as assigned by management

Date Posted: 21 May 2024
Job Expired - Click here to search for similar jobs