Role: Mechanical Engineer (CFNJP00046816)

Location: Brea, CA
Duration:12 months, with the preferred start date in early to mid-December.
Bill Rate: $50/hr
Pay Rate:$35/hr
Hiring Manager: Jessica He
On-site at the Brea lab, five days a week.

Hello,
Hope you are doing great.

This is Gangadhar from Intellectt INC; we have an immediate opportunity with one of our clients. Please find the
below job description and if you are interested, please forward your resume to gangadhar@intellectt.com

Role: Mechanical Engineer

Location: Brea, CA
Duration: 12 months

Description:
 Focusing on remediating design history files for 17 product lines related to EU MDR compliance.
 The focus is on driving deliverables to closure, particularly in remediating design history files for 17 different
product lines.
 The ideal candidate should possess strong attention to detail, familiarity with EU MDR, and experience in the
medical device industry.
 Responsibilities include going through legacy documentation, identifying gaps in design verification data,
planning design verification testing, conducting feasibility testing, and managing coordination with the lab.
 Root cause investigation and problem-solving skills are crucial, as the role involves addressing defects in
existing products.
 A thorough understanding of design controls and experience in medical device industry procedures is
emphasized.
 The desired candidate should have senior-level experience, preferably in design and mechanical engineering.
 Testing experience, verification testing, and defect management experience are highlighted as essential.
 The candidate must have access to the Brea lab and be able to be on-site five days a week.
 The team is described as global, with members across the West Coast, East Coast, Europe, and India.
 Flexibility in working hours is expected to accommodate different time zones.

Experience:
 Senior role requiring 2-3 years of experience.
 Background in design and mechanical engineering.
 Essential experience in testing, verification testing, and defect management.
 Familiarity with design controls and medical device industry procedures.

(“Mechanical Engineer”) AND (“remediation”) and (“design”) and (“MDR”) and (“Testing”) and (“Documentation”)
and (“Medical” or “ISO” or “FDA”)