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Job Title: 

Project Engineer Bi Lingual In Japanese

Job ID: 

mrsa1149

Location: 

Paterson, NJ

Industry: 

Medical Device

Job Type: 

Full time

Description: 
Project Engineer will be responsible for the planning, organization and implementation of design activities to obtain regulatory approval for new and revised medical devices for the Japanese market. Ensure compliance to Japanese requirements and corporate policies regarding submissions for market release.

Responsibilities: 
Detailing andd modeling of implant and instrumentation designs utilizing the PRO E design software, development of prototypes for design verification and validation. Candidate should demonstrate strong interpersonal skills, written and oral communication and organizational and planning skills. Develop and manage project plans and time lines. Detailed knowledge of design controls; experience in PMDA/FDA regulatory requirements preferred.

Requirements: 
4+ years of product design experience in the medical device industry or equivalent. Familiarity with design controls with in a regulated industry. Parametric CAD design package experience, preferrably PRO E. Must be fluent in Japanese.

MUST BE AUTHORIZED TO WORK IN THE US, SPONSORSHIP AND TRANSFER OF H-1B VISA NOT AVAILABLE.

Education: 
B.S. Bachelors degree in Mechanical or Biomedical Engineering

Compensation: 
$70,000 to $85,000

Contact: 

Management Recruiters of Santa Ana Inc.
17853 Santiago Blvd.
# 107-168
Villa Park, CA 92861
Tel: (714) 565-0010 Ext: 110
Fax: (714) 565-0020
resume@socalmri.com