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.

#WCL

Job Types: Full-time, Contract

Pay: $56.00 - $63.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Education:

• Bachelor's (Required)

Experience:

• Medical Device: 5 years (Preferred)
• In Vitro Diagnostics: 5 years (Preferred)
• Process engineering: 5 years (Required)

Ability to Commute:

• Santa Clara, CA 95050 (Required)

Work Location: In person