Manufacturing Engineer II - Shockwave

Role Summary

Manufacturing Engineer II - Shockwave

Location: Santa Clara, CA (United States)

Responsibilities

• Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
• Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
• Coordinate and/or perform functional and destructive testing to support Engineering Reports. Document the results and provide a statistical analysis using Minitab or excel.
• Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
• Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents.
• Create, maintain and transfer paper Bill of Materials (BOM‚Äôs) and Lot History Records (LHR‚Äôs) into Item Structures, Work Definitions and electronic LHR‚Äôs.
• Support efforts to resolve Quality related events (NCR, CAPA, Audit Finding) and maintain other Quality System Requirements.
• Create and release label files used for printing product labels.
• Create and execute process validation protocols and reports.
• Other duties as assigned.

Qualifications

• Bachelor‚Äôs degree in engineering.
• 3-5 years of experience in a medical device environment.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
• Understanding of Lean and Six Sigma concepts.
• Experience with Validation of Medical Devices (IQ-OQ-PQ).
• Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE‚Äôs, Gage R&R) a plus.
• Able to create and maintain Drawings in SolidWorks.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Experience with MES and ERP (Oracle) preferred
• Employee may be required to lift objects up to 25lbs or more.
• Employee will be required to work in an air-conditioned Class 8 Cleanroom.

Skills

• Process improvement
• Quality systems and regulatory compliance
• Lab testing and data analysis
• Documentation and BOM/LHR management
• Process validation and testing
• SolidWorks CAD
• Lean Six Sigma principles

Education

• Bachelor‚Äôs degree in engineering (required)

Additional Requirements

• Must be able to work in a cleanroom environment (Class 8).