Technical Specialist \- Product Development jobs in United States
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CameleonHR · 2 months ago

Technical Specialist \- Product Development

CameleonHR is supporting Medicom, a global leader in the medical device industry, in recruiting a Technical Specialist. This role involves contributing to the development and improvement of medical device products while ensuring compliance with design control activities in a highly regulated environment.

Human Resources

Responsibilities

Execute product design and development activities (medical device)
Support both new product development and sustaining engineering initiatives
Participate in design control execution: specifications, V&V, design reviews, labeling, risk management
Support design transfer to manufacturing
Ensure compliance with CMDR, FDA QSR, ISO 13485, CDC NIOSH and EU MDR requirements
Support audits (FDA, notified bodies) and remediation activities if needed

Qualification

Medical device developmentDesign control executionRegulatory complianceContinuous improvementDesign transferMulti-stakeholder collaborationTechnical certification

Required

Bachelor's degree in engineering, science or related technical field
2+ years of experience in a regulated medical device environment (R&D, Quality, Compliance or Regulatory)
Ability to work in a multi-stakeholder / contract manufacturing context

Preferred

Master's degree or relevant technical certification
Experience in continuous improvement or design transfer

Company

CameleonHR

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At Cameleon HR, we’re recognized as THE go-to firm specializing in attracting, sourcing, recruiting, and onboarding services.

Funding

Current Stage
Early Stage
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