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Product Support Engineer
Ref No.: 18-07820
Location: Lake Forest, California
Position Type:Engg
Start Date / End Date: 06/04/2018 to 07/03/2021
Job Title: Product Support Engineer
Duration: 3 years
Location: Lake Forest, CA

Job Description:


The CLIENT's Research, Medical Device Company in Lake Forest, CA (Orange County) is currently seeking engineering candidates with electromechanical/mechanical experience for a temporary assignment. To be considered for this temporary position opportunity, you must reside in the immediate area or be willing to relocate at your own expense. No relocation assistance will be provided overall

Summary:
The successful candidate will be responsible for completing work requests as assigned by engineering teams and management.

This positon will provide needed support to Manufacturing project requests (cost improvements, obsolescence, corrective actions) for electromechanical/mechanical post market products:
  • Analyze and trouble shoot design and process changes, document impact on product design to support electrical/electromechanical design and process changes, complaint and risk analysis, technical file and product compliance documentation for Surgical Instrumentation products.
  • This position will also support project activities required for compliance to new European Medical Device Regulation (MDR), including managing and reporting technical product data, materials remediation, labeling updates and technical file updates (required to maintain European registration (CE mark) and will work to maintain product compliance to existing and future regulations and product test standards and reporting (EN, ISO, etc.)
Skills:
  • 5+years of experience ideally in the medical device industry
  • Experience with product Verification & Validation
  • Medical Device Design Control including risk assessment, management and reporting
  • Experience with Corrective and Preventative Action (CAPA) including root cause analysis, problem solving and redesign of devices to meet requirement
  • Familiar with PRO-E and other Windchill product data management applications is preferred
  • Excellent written and spoken communication skills
  • Proficient in MS Office applications
Education:
  • Bachelors in Engineering – Electrical, Electromechanical, Mechanical Engineering preferred
Certifications & Licenses: CAPA

Anant Dwivedi | Lead Recruitment
Sunrise Systems Inc, 
105 Fieldcrest Ave Suite# 504, Edison, NJ - 08837 USA
Desk: (732)-272-0289
Email: mailto:Anant.K@sunrisesys.com URL: http://www.sunrisesys.com