, assembly, supplier, or other production issues encountered during NPI. Works with project teams to produce DHF reports...
and competencies BS Degree, Engineering PMP Certification Background in medical device development Knowledge of DHF, DMR...
or participate in audits, as needed. Support external regulatory audits as needed. Support DHF compliance assessments to ensure...
activities. Ensure DHF content completion, integrity, and regulatory & standards compliance;collaboratively communicating...
in drafting relevant technical documentation (e.g., DHF, DMR). Assist in executing risk management processes, participate...
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...