Previous Job
Previous
Medical Device Engineer
Ref No.: 18-00675
Location: Irvine, California
Position Type:Contract
Start Date: 05/16/2018
MEDICAL DEVICE ENGINEER
IRVINE, CA

Project Description:
Our client is looking for a candidate to fill an engineering position within the Device Product Development group. The position requires excellent technical skills, and knowledge of good design principles.
  • Responsible for test method development and validation; will be involved in investigation efforts, design feasibility and verification testing, and responsible for documentation of performed tests, analysis etc.
  • Will be working with vendors (both manufacturing and development partners). The time is split between lab and desk, ~50/50. The candidate may present the functional group in various teams.

Required Skills:
  • BSc in an Engineering discipline (mechanical or similar), and has at least 5 (five) years of experience in medical device development.
  • Has performed tolerance stack up analysis and uses Solid Works daily.
  • Experience performing root cause analysis.
  • FDA rules regulating the medical device and combination product development; has used elements of design controls and risk management in design development.
  • The candidate has been a part of development team, and works well in cross-functional teams.
  • Understands basic principles of molded plastic part design and is familiar with conventional manufacturing technologies.
  • Will be able to manage outsourced development efforts.
  • Is able to travel up to 10% of the time.
  • In addition to the above requirements, the following are DESIRED skills/experiences, but are NOT required:
    • Masters of Science degree
    • Experience developing combination products (device portion)
    • Pen injectors, Auto-injectors development and regulatory requirements
    • DOE
    • FEA
    • Experience with usability engineering requirements, and usability specifications
    • Authoring sections in various regulatory submissions
    • Software:
      • Minitab
      • Matlab
      • MS Project
      • Labview
      • MS Office Suite

This 13+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Karen: karen@alphaconsulting.com

ALPHA'S REQUIREMENT #18-00675
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE