Role: Senior Remediation Engineer / Technical Lead
Location: Skaneateles, NY

• EU MDR Remediation
• Gap Assessment
• Design History File (DHF) & Device Master Record (DMR) Updates
• Manufacturing Processes
• FDA 510(k) Submissions & Non-Conformance Audits

• Lead the remediation of Manufacturing, DHF, and DMR documentation for both new and legacy products, ensuring compliance with current organizational standards and regulatory requirements.
• Conduct gap assessments, collaborate with stakeholders, and implement necessary updates to documentation.
• Ensure compliance with EU MDR, FDA 510(k), ISO 13485, and ISO 14971 standards.
• Support quality systems development, regulatory compliance, and process risk management (pFMEA) for new products, processes, and technologies.
• Develop and update process flows, manufacturing/service work instructions, and related documents.
• Design, modify, and validate fixtures, tooling, equipment, and systems to support operations.
• Understand and document IQ, OQ, and PQ requirements for manufacturing equipment.
• Drive corrective actions, CAPA initiatives, and continuous improvement by conducting investigations, data analysis, and process enhancements.
• Collaborate with cross-functional teams to support non-conformance audits and regulatory documentation remediation.
• Work efficiently in a fast-paced environment, adapting to changes and contributing as a team player.

• 5+ years of experience in leading and managing remediation projects in a regulated environment.
• Strong background in ISO 13485-certified and cGMP organizations.
• Hands-on experience with DHF/DMR remediation, QMS documentation, and gap assessments.
• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or Industrial Engineering (or related field)