Senior Project Engineer
development Create and maintain project plans and FDA complaint Design history Files (DHF) for each project Manage...
development Create and maintain project plans and FDA complaint Design history Files (DHF) for each project Manage...
of project plans and Design history Files (DHF) for each project Partnering with engineers on several aspects of various...
Analysis to identify impact of change - specifically Changes impacting DMR, and DHF Review incoming change requests...
related projects. a. Project planning issues b. Compliance Activities (DHF Audits, Traceability, etc.) c. Verification..., FMEAs, etc.) Monitor and maintain DHF requirements in accordance with project timeline and design control requirements...
, specifications, and control strategy Efficient and cost-effective execution of validation and verification Maintain DHF, design... and testing to meet external standards Ensure DHF content completion, integrity, and regulatory and standards compliance...
and inspection method development, and lead method validation activities. Ensure Device History File (DHF) content completion...
DHF and DMR documentations Ability to independently develop and adapt work plans based on vague or changing project goals...
, FMEAs, DMR, and DHF documents, etc. Support production on both sustaining activities and new products development from line...
elements during internal and external audits. Includes leading design control gap assessments (DHF audits). Assist...
(DHF) and Risk Management File (RMF) assessments. · Develop and/or review controlled documents (e.g., protocols, reports...