Process Development Engineer
Location: Santa Clara, CA
Hourly rate: $56.00 - $63.00
Contractor benefits: Medical, Vision, Dental, 401k
Required:
• 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.
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.
• 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.
• 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 company 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.
• 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.
Must be U.S. Person for purposes of Export Compliance.
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
