Role: Design Engineer (PLM)

Duration: 12+ Months

Location - Irvine, CA

Role Description: Design Quality, good manufacturing practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, Manufacturing Process

Competencies: EIS : Medical Device & Regulations

Experience (Years):b4-6

Essential Skills:

GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs

• Strong creative, analytical and problem-solving skills.• Proficient at interpreting data and putting that data into a report
• Proficient at statistical analysis
• Root Cause Analysis
• Strong CAD Skills (Preferred Auto CAD and Solidworks)
• Strong Fixture design skills
• Experience in creating FMEAs & Writing reports
• Experience in PMS (Post Market Surveillance)
• Experience in PLM Tool (Windchill)
• Process experience, ability to observe and understand manufacturing processes
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)

Keywords:

Design Quality, Good manufacturing practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, Manufacturing Process

Thanks & Regards,

Beauty Rani |ACCURO GROUP|

Direct: 919-676-8033

EMAIL [email protected]