Process Engineer

Hi,

We have a very urgent requirement for Process Engineer Please let me know if you or someone you know is interested.

Please see the job details below.

Job Title: Process Engineer

Employment Type: Contract W2 (Minimum 12 months project)

Location: Santa Clara, CA (Onsite Position - Local Candidates)

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 s 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

Kakuli Estuate, Inc.

P :

E:

830 Hillview Ct Milpitas, CA 95035