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