Engineer II, Regulatory & Product Safety

Irvine, CA 92618

Employment Type: Contract to Hire Industry: Engineering Job Number: 17231 Pay Rate: 33.00-52.00 BOE

Job Description

Irvine based Medical Device Company is adding to their team.  

Engineer II, Regulatory & Product Safety
Temp to Hire 

Job Summary:
The Engineer II, Regulatory and Product Safety is responsible for providing technical support for all aspects of regulatory and product safety throughout the product realization process.  This position will handle projects from product inception, development, through manufacture and customer use. The incumbent provides support to ensure product meets defined safety standards and worldwide regulatory requirements. 
Duties & Responsibilities:
  • Supports new product development through the application of safety standards and regulatory requirements;
  • Supports developing Risk Analysis according to ISO 14971/ IEC 60601-1, 3rd Edition;
  • Provides support for various product certification agencies such as Intertek and external laboratories to obtain product safety certifications to applicable product safety standards (i.e., IEC 60601-1, 3rd Edition, ISO 80601-2-61, etc.)
  • Works to be knowledgeable in product safety standards
  • Supports design reviews to applicable product safety standards.
  • Responsible for creating in-house product safety reports aligned to IEC formats for pre-compliance design reviews.
  • Support international and domestic filings/registrations, including updating technical files and design dossiers;
  • Coordinate with international regulatory team members on product changes and regulatory notification/ approval requirements;
  • Maintain up-to-date knowledge on international and domestic regulatory requirements;
  • Update and Maintain EU Technical Documentation Summaries and Declaration of Conformities;
  • Work with internal engineers on test protocols and test requirements as specified by regulatory health authorities and notified bodies;
  • Provide guidance to other departments on IEC/ISO requirements (e.g., electrical safety, EMC, software)
Minimum & Preferred Qualifications and Experience: 
Minimum Qualifications:
  • Three or more years of experience in product safety or equivalent;
  • Direct experience with IEC 60601-1, 3rd Edition;
  • Proficiency with Microsoft Office applications;
  • Strong communication, documentation, and problem solving skills;
  • Must be an independent worker, who is flexible and adaptable.
Preferred Qualifications:
  • Experience with IEC 60601-1, 3rd Edition
  • Experience generating IEC formatted test reports
  • Experience in evaluating products to Product Safety Standards
B.S. in Science or Engineering is required. M.S. in Science or Engineering is a plus.
The anticipated range for this position is $33.00ph - $52.00ph.  Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.


Meet Your Recruiter

Nina McCann
On-Site Manager

A native to Orange County, Nina’s staffing career began in 2006 placing quality engineering candidates with distinguished companies as a successful recruiter and client manager. Nina specializes in recruiting for mechanical and electrical engineers in all industries from aerospace, medical device and manufacturing. She understands the engineering programs and importance of matching specific technical skills for position success. Her strong connections within the industry have been vital in her success. Nina’s excitement in placing engineers is due to the direct impact the products have on people’s lives: Everything we touch has been engineered in one form or another. She currently works as an on-site manager at a prominent medical device company.

Outside of work, Nina has been a dedicated volunteer to local nonprofit organizations for the past 15 years. She also enjoys being outdoors, hiking and spending time with her three children.

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