Senior Process Engineer
PFMEA and implement mitigation strategies for high-volume production risks. Maintain DHF and DMR documentation...
PFMEA and implement mitigation strategies for high-volume production risks. Maintain DHF and DMR documentation...
intent. Maintain documentation within DHF and ensure all activities meet regulatory and internal compliance expectations.... Must-Have Skills Strong engineering background with hands-on experience in design controls, V&V, DHF documentation, and risk...
to ensure alignment with design intent. Maintain documentation within DHF and ensure all activities meet regulatory... controls, V&V, DHF documentation, and risk management. Ability to read and interpret mechanical drawings. Solid...
intent. Maintain documentation within DHF and ensure all activities meet regulatory and internal compliance expectations.... Must-Have Skills Strong engineering background with hands-on experience in design controls, V&V, DHF documentation, and risk...
(Quality, Regulatory, Manufacturing, and Supply Chain). Create and maintain technical documentation Design History File (DHF...
and approve Design History File (DHF) documents, ensuring compliance to design control requirements. EDUCATION & EXPERIENCE...
., DHF) and applies clinical knowledge to create accurate design inputs. Strong foundation in mechanical engineering...
assessments. Act as a divisional expert in applying medical device standards and reviewing design documentation (e.g., DHF...
lean and six sigma initiatives in a regulated environment Led and managed development of DHF (design history file...
Design History File (DHF) updates in collaboration with Development device teams Support the creation and maintenance...