(DHF) Remediation Specialists with a proven track record in medical device product development and a deep understanding...&D Product Development, and have a thorough working knowledge of VAULT document management systems. Responsibilities: DHF...
and competencies BS Degree, Engineering PMP Certification Background in medical device development Knowledge of DHF, DMR...
of current European Medical Device directives (MDD/MDR) and CE Mark process, Experience in Remediation of QMS, Tech File, DHF...
projects on timelines and with quality. Applies principles of SDLC and owns product DHF while complying with QMS processes...
DHF/DMR documentation including but not limited to failure analyses, risk management activities, FMEAs (application...
DHF/DMR documentation including but not limited to failure analyses, risk management activities, FMEAs (application...
adequately address safety and efficacy and are compliant to the highest standards. Perform DHF audits of other products...
developing the DHF and all required documents within (i.e. PRD, DIR, V&V matrix, Risk Mgmt, Design Reviews and Design Transfer...
testing;DHF maintenance;and provide support to other departments as required. Essential Job Functions Design and develop... of medical device experience. Familiarity with Design History Files (DHF), Design Master Records (DMR), Traceability Matrices...
and development;test and report writing and development;execute testing;DHF maintenance;and provide support to other departments... with 3+ years of medical device experience. Familiarity with Design History Files (DHF), Design Master Records (DMR...