projects, including risk management file creation, design verification/validation, and development of Design History File (DHF... from conception to commercialization. Plan and oversee release testing for new products. Ensure DHF and Device Master Record (DMR...
specifications for new product development Creates and maintains project plans and FDA complaint Design history Files (DHF...
detailed Safety, EMC and Wireless verification test plans and test reports. Provide timely DHF deliverables fully compliant...
File (DHF) and associated documentation. Responsible for quality oversight and approval of software product development...
. Support design test and inspection method development, and lead method validation activities. Ensure DHF content integrity...
Device History File (DHF) content completion, integrity, and regulatory & standards compliance;collaboratively identifying...
to product families established by EU MDR and Design History File (DHF) remediation program. Provide data to support the gap...
during product or supplier changes Maintain DHF, design input / design output, external requirements, and risk management... external standards and implement product requirements and testing to meet external standards Ensure DHF content completion...
projects. Project planning issues Compliance Activities (DHF Audits, Traceability, etc.) Verification and Validation Status..., FMEAs, etc.) Monitor and maintain DHF requirements in accordance with project timeline and design control requirements...
on performing Design History File (DHF) remediations, writing Procedures and Test Method Development. Projects Include: Project... 1 - Assisting with Developing PRCDs for Internal DVT Project 2 - DHF Remediation for Commercial Projects Project 3...