Job Details

ID #15199193
State California
City Menlopark
Job type Contract
Salary USD $70 - $90 per hour 70 - 90 per hour
Source Real Staffing
Showed 2021-06-07
Date 2021-06-07
Deadline 2021-08-06
Category Architect/engineer/CAD
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Systems Engineer

California, Menlopark, 94303 Menlopark USA

Vacancy expired!

Job Function:

This person will help with verification & validation of new products going through FDA certifications. They will help determine feasibility of new products and sustainability of products already on the market.

The candidate will help with product development through defining concepts, requirements, architecture/design, and testing. A successful candidate will have experience working in bio, pharma, mechanical, electrical or software engineering.

A successful candidate will have at least 5 years of experience and be able to interact with engineers of all disciplines and work with both internal and external teams.

Responsibilities May Include:

  • Ensure products consistently meet customer requirements and industry regulations
  • Perform feasibility evaluations
  • Perform failure root cause analysis (FMEA, FTA, 5 why, Fishbone)
  • Perform traceability analysis
  • Support FDA and other regulatory submission and audits to maintain regulatory compliance
  • Transfer designs to manufacturing
Must Have Technical Requirements:

  • Ability to code in python
  • Experience with CAD designs (preferably solidworks)
  • Experience interfacing with electromechanical systems
  • Experience debugging mechanical systems
  • Familiar with FDA design controls (ISO 13485, IEC 62304, IEC 61010, and ISO 14971)
  • Experience with Risk management activities (ISO 14971)
  • Experience with systems verification and validation
Additional Requirements:

  • Experience working within Med Device industry (IVD industry a plus)
  • Experience with reliability design a plus
  • Electrical engineering background a plus (knowledge of PCB design, layout etc.)
  • Experience with Design Controls around user needs, intended use, system requirements, design and traceability
  • Bachelors or Masters Degree in related field

THIS IS NOT A C2C OPPORTUNITY

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Vacancy expired!

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