Product Safety Engineer - medical Devices, IEC 60601-1

irvine, California

Hybrid

Contract

$80/hr - $100/hr

Our client, located in South Orange County, is one of the largest medical device makers within the optical surgery space. They are urgently seeing a Laboratory Safety Engineer to work hands-on in their Labs on the medical devices. They continue to grow their departments and add new engineers monthly. 

This is a hybrid 4x a week onsite position, so they would need to be local to the south orange county area or norther San Diego. 

Role Requirements:
  1. Minimum Education and Experience:
BS + 4+ years in medical device products safety compliance, and/or fully accredited test labs such as UL, CSA, Intertek or Element, etc.
  1. Working knowledge of IEC 60601-1 3rd Ed (3.1 and 3.2) of medical electrical equipment standards and including particulars & collateral standards.
  2. Proven experience in successfully being able to work with cross functional teams
Core responsibilities:
  • Perform Safety certification test assessments throughout the development lifecycle including early stages to provide the necessary inputs to R&D to drive product development.
  • Support development including planning, communicate periodic status and known risks (with proposed solutions) on the projects to R&D core teams
  • Capable of performing safety testing and of Alcon products in the Alcon safety Lab and external labs.
  • Prepare documentation to execute safety certification activities – Isolation Diagrams, perform Dielectric and Leakage current testing, Construction evaluation using IEC generated test reports forms
  • Communicate with internal/external labs, technicians, and design engineers to accomplish timely/valuable results at optimal cost (from Quote request to final deliverables).
  • Collaborate with teams to ensure full execution of identified required testing and review activities needed to ensure product compliance including de-risking product launches through pre-verification test rehearsals.
  • Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed Safety verification test plans and test reports.
  • Effectively communicate complex concepts in formal/informal presentations and in technical reports; proven technical writing skills is required (assessed during interview).
  • Experience with Safety testing of electrical equipment and certification for global market access.
  • Experience with Product Safety testing requirements and procedures.
  • Experience with use and maintenance of commonly used safety equipment, and calibration procedures.
  • Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety compliance, and/or fully accredited test labs.
The Offer:
  • 80-100/hr pay rate DOE
  • W2 Employee Benefits
  • potential for full-time offer after the contract is over.
Motion Recruitment partners

You will receive the following benefits:

  • Medical Insurance - Four medical plans to choose from for you and your family
  • Dental & Orthodontia Benefits
  • Vision Benefits
  • Health Savings Account (HSA)
  • Health and Dependent Care Flexible Spending Accounts
  • Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance
  • Hospital Indemnity Insurance
  • 401(k) including match with pre and post-tax options
  • Paid Sick Time Leave
  • Legal and Identity Protection Plans
  • Pre-tax Commuter Benefit
  • 529 College Saver Plan

Motion Recruitment Partners is an Equal Opportunity Employer, including Veterans/Disability/Women. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Accommodation will be provided in all parts of the hiring process as required under Motion Recruitment Employment Accommodation policy. Applicants need to make their needs known in advance.

Posted by: Kevin Gabrielson

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