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Process Development Engineer

3 months ago

India Dawar Consulting, Inc. Full time
Job Description

Our client, a world leader in diagnostics and life sciences, is looking Process Development Engineer. Kindly have a look at the details below and let us know if you are interested.

Job Title: Process Development Engineer

Job Duration: Long Term Contract(Possibility Of Extension)

Location: Santa Clara, CA

Company Benefits include:

Healthcare (Medical, Dental, & Vision)

Paid Sick leave

401k (with 2% employer match)

Responsibilities:

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:

· 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 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:

· 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 (CAPA s) and Non-Conformance Reports (NCR s) and provide technical input as needed to remediate discrepancies

· Support regulatory inspections and audits by providing technical expertise and documentation as needed

Formal Training/Education:

· 5-8 years in Medical Device or In Vitro Diagnostics

· BS in relevant field.

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

If interested, please share your update resume at /

Requirements
Process development, method validation, medical devices, IVD