Job Requirements
Job Description
Who We Are:
Quest Global delivers world-class end-to-end engineering solutions by leveraging our deep industry knowledge and digital expertise. By bringing together technologies and industries, alongside the contributions of diverse individuals and their areas of expertise, we are able to solve problems better, faster. This multi-dimensional approach enables us to solve the most critical and large-scale challenges across the aerospace & defense, automotive, energy, hi-tech, healthcare, medical devices, rail and semiconductor industries.
We are looking for humble geniuses, who believe that engineering has the potential to make the impossible possible; innovators, who are not only inspired by technology and innovation, but also perpetually driven to design, develop, and test as a trusted partner for Fortune 500 customers. As a team of remarkably diverse engineers, we recognize that what we are really engineering is a brighter future for us all. If you want to contribute to meaningful work and be part of an organization that truly believes when you win, we all win, and when you fail, we all learn, then we’re eager to hear from you. The achievers and courageous challenge-crushers we seek, have the following characteristics and skills.
What You will Do:
Safety Engineer - Medical products – 6+ Years Experience
Primary Job function -
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Experience with Safety concepts, standards and test methods and how they relate to products. Facilitates a systems-level approach to Product Safety compliance for new product development and design changes to existing product.
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Working knowledge of test set up and execution as required per UL/CSA/IEC 61010-1 and 61010-2-101 and other 61010 particulars as applicable. Provides guidance to test technicians and junior engineers on Product Safety test setup, execution and troubleshooting.
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Actively participates in UL witness testing with UL engineers for changes to existing product and new product launches.
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Conduct quarterly UL audits for company manufactured product and ISO 17025, addresses any variation notices.
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Performs basic EMC/Safety assessments for design changes to existing product, providing design recommendations to R&D engineers and management. Regularly communicates directly with UL/EU Notified Body on design changes
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Creates/updates IEC 60825-1 and CDRH laser reports according to Form FDA 3632.
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Perform regulatory impact assessments for new product standards and/or changes to existing standards affecting company products.
What You will bring:
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Hands-on technical knowledge and expertise of Product Safety test methods and test equipment, procedures, and standards.
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Completes professional level engineering assignments related to Product Safety. Leads and participates in projects involving the design, fabrication, and manufacture of complex instrument subassemblies, systems or processes.
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Collaborates across functional areas, including engineering, project management and other systems development personnel.
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Maintains test capability by researching required test equipment to align with regulatory changes and/or product changes/enhancements.
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Creates and/or maintains internal test procedures according to associated external test method standards, directives and regulations.
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Responsible for implementing and maintaining the effectiveness of the quality system.
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Maintains lab areas in a state of audit readiness, following cGMP practices. Assists with metrology requirements for equipment calibration and OOT assessments.
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Consistently meets timelines for the completion of Product Safety related activity in support of program timelines.
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Strong organizational skill, follow-up and attention to detail. Strong written and verbal communication skills.
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Travel as necessary to aid in program facilitation or for training (5%)
Qualifications/Experience/Education Requirements
Basic Qualifications:
Bachelor's degree in an engineering or closely related discipline with 6+ years progressive work experience in laboratory environment, field service, Safety and/or with Abbott Diagnostics products.
Preferred Qualifications:
Bachelor’s Degree in Electrical, Mechanical, or Biomedical Engineering with a minimum of 6+ years work experience in Medical Device Product Safety testing.
Pay Range:$45-$55/hr on C2C
Work Requirements:
This role is considered an on-site position located in Irving, TX
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You must be able to commute to and from the location with your own transportation arrangements to meet the required working hours.
