of implantable device DHF's to ensure compliance. Required Qualifications: Bachelor's degree in mechanical engineering, Biomedical...
efficient long-term solutions. Ensure DHF content integrity, completeness, and regulatory / standards compliance...
and completeness of the Design History File (DHF) Ensure alignment between DHF and Device Master Record (DMR) during design transfer... assessment on DHF and risk management files, implementation of corrective actions, and verification of effectiveness...
, and validation. Support design reviews, phase gate readiness, and Design History File (DHF) completeness. Lead and support risk...
, with the purpose of identifying the underlying issues and offering efficient long-term solutions. Ensure DHF content integrity...
, phase gate readiness, and Design History File (DHF) completeness. Lead and support risk management activities per ISO 14971...
21 CFR Part 820 and ISO 13485. Author and maintain inspection-ready Design History Files (DHF). Support regulatory...
and ensure compliance with IEC 62304/82304. Support supplier qualification, design transfer, and DHF completeness. Contribute...
, risk controls, verification, and validation. Support design reviews, phase gate readiness, and Design History File (DHF...
risks. Ensure all control measures feed directly into the Risk Management File and the Design History File (DHF...