DHF Process Engineer

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Company Description Gentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.
Our success is a result of the talents, dedication and commitment of our people to drive our business forward. We provide career advancement opportunities through Gentell University, leadership development programs and executive mentoring. You would be joining a company committed to “make it better” every day, for our customers and for our employees.
Role Description The DHF Process Engineer will play a critical role in ensuring the quality and regulatory compliance of medical device products throughout their lifecycle - from concept through to commercialization. This position is responsible for leading and project managing design control activities in accordance with ISO 13485, ISO 14971, UKCA, EU MDR, MDSAP, FDA and other applicable standards. Working cross-functionally with engineering, manufacturing, regulatory, technical and supply chain teams, the DHF Process Engineer will ensure that product development processes and documentation is robust, audit-ready, and aligned with ...
Location:
Marlborough
Job Type:
FullTime
Category:
Engineering

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