Find Great People | FGP ยท 1 month ago
Product Engineer - Medical Device
Columbia, South Carolina Metropolitan Area
Full-time
Onsite
Mid Level
3+ years expFind Great People (FGP) is seeking a Product Engineer for custom medical device development in Columbia, South Carolina. The role involves leading projects from concept to validation, ensuring compliance with safety and quality standards while collaborating with cross-functional teams.
ConsultingHuman ResourcesInformation Technology
Hiring Manager
Tonya Hendley Bowers
Responsibilities
Lead custom medical device projects from concept through verification and validation
Create prototypes, perform tests, and validate materials and processes
Ensure comprehensive documentation of all design, testing, and validation activities
Collaborate closely with manufacturing, quality, and operations teams to support product transfer
Prepare justification and control documents to meet regulatory standards
Support small-team project management, ensuring timelines and compliance requirements are met
Assist in sustaining engineering improvements and updates for existing custom products
Qualification
Required
Bachelor's degree in Mechanical, Electrical, or Biomedical Engineering
3+ years of experience in product development with medical devices
Strong experience with documentation, regulatory compliance, and design control processes (ISO 13485, ISO 14971, FDA 21 CFR 820, ASTM)
Proficiency with CAD tools (SolidWorks preferred)
Hands-on approach to testing, validation, sterilization, and packaging processes
Comfortable working in a small team environment with close collaboration
Detail-oriented and organized, with a focus on compliance and traceability
Preferred
Proficiency with CAD tools (SolidWorks preferred)
Company
Find Great People | FGP
Find Great People (FGP) is a nationally recognized talent acquisition and human resources consulting firm.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Betsy Anthony
Chief Operating Officer, Senior Talent Consultant
Recent News
London Loves Business
2024-02-05
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