Product Certification Safety- EE Contractor

Lake Forest, CA, US • Posted 30+ days ago • Updated 4 hours ago

Contract Independent

On-site

USD $50.00 - 75.00 per hour

Judge Group, Inc.

Fitment

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Job Details

Skills

ISO 9000
Risk Management
Product Development
Research and Development
Electrical Engineering
Documentation
Reporting
Forms
Quoting
Collaboration
Medical Devices
ISO 13485
Test Plans
Regulatory Compliance
QMS
Testing
Presentations
EMC
Management
Technical Writing
Privacy
Marketing

Summary

Location: Lake Forest, CA
Salary: $50.00 USD Hourly - $75.00 USD Hourly
Description:
Minimum Qualifications

Education: Bachelor's degree in Electrical Engineering or related field.
Experience: 4+ years in medical device product safety compliance evaluations or experience in fully accredited test labs (e.g., UL, CSA, Intertek, Element).
Expertise: Deep knowledge of IEC 60601-1 3rd Edition (including 3.1 and 3.2), collateral and particular standards for medical electrical equipment.
Collaboration: Proven ability to work effectively with cross-functional teams.

Preferred Qualifications

Working knowledge of ISO 14971 Risk Management for Medical Devices.
Familiarity with EMC test planning and procedures per IEC 60601-1-2.
Strong technical writing and presentation skills.

Responsibilities

Perform safety certification assessments throughout the product development lifecycle, including early-stage evaluations to guide R&D.
Plan and execute safety testing of electrical equipment for global market access.
Conduct safety testing on Alcon products in internal and external labs.
Prepare and maintain documentation for certification activities (e.g., isolation diagrams, dielectric and leakage current testing, construction evaluations using IEC test report forms).
Communicate with internal/external labs, technicians, and design engineers to ensure timely, cost-effective results from quote to deliverables.
Collaborate with teams to execute required testing and reviews, including pre-verification rehearsals to de-risk product launches.
Document and execute all V&V tests in compliance with medical device QSR and ISO 13485.
Develop detailed safety verification test plans and reports.
Ensure compliance with product safety testing requirements and Alcon QMS standards, including production equivalency for test samples.
Maintain and calibrate safety equipment; provide guidance to external labs for certification testing.
Effectively communicate complex concepts through presentations and technical reports.

Skills

Strong understanding of IEC 60601 standards and EMC practices.
Ability to manage multiple projects and communicate risks with proposed solutions.
Technical writing proficiency (assessed during interview).

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Contact:

This job and many more are available through The Judge Group. Please apply with us today!

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: cxjudgpa
Position Id: 1110015
Posted 30+ days ago

Company Info

About Judge Group, Inc.

The Judge Group, is a leading professional services firm specializing in talent, technology, and learning solutions. We consult, staff, train, and solve. Through our work we make people and organizations better.

Our services are successfully delivered through a network of more than 30 offices across the United States, Canada, and India. The Judge Group is proud to partner with the best and brightest companies in business today, including over 60 of the Fortune 100. We serve organizations in financial services, healthcare, life sciences, insurance, government (including aerospace and defense), manufacturing, and technology and telecommunications.

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