Product Engineer – Custom Product Development
Columbia, South Carolina
Are you an engineer who enjoys turning innovative concepts into real-world medical solutions while managing detailed documentation? We are seeking a Product Engineer to join a small, collaborative team focused on custom medical device development. This role emphasizes thorough documentation, regulatory compliance, and cross-functional collaboration.
Qualifications:
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Bachelor’s degree in Mechanical, Electrical, or Biomedical Engineering
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3+ years of experience in product development, ideally with medical devices
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Strong experience with documentation, regulatory compliance, and design control processes (ISO 13485, ISO 14971, FDA 21 CFR 820, ASTM)
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Proficiency with CAD tools (SolidWorks preferred)
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Hands-on approach to testing, validation, sterilization, and packaging processes
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Comfortable working in a small team environment with close collaboration
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Detail-oriented and organized, with a focus on compliance and traceability
Responsibilities:
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Lead custom medical device projects from concept through verification and validation
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Create prototypes, perform tests, and validate materials and processes
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Ensure comprehensive documentation of all design, testing, and validation activities
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Collaborate closely with manufacturing, quality, and operations teams to support product transfer
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Prepare justification and control documents to meet regulatory standards
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Support small-team project management, ensuring timelines and compliance requirements are met
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Assist in sustaining engineering improvements and updates for existing custom products
Why Join Us:
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Work on meaningful, innovative medical devices that directly impact patient care
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Collaborate in a close-knit team where your contributions are highly visible
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Gain experience managing end-to-end product documentation and regulatory compliance
