Head of Manufacturing Engineering - Indianapolis, United States - Catalyst Life Sciences

Description

The client is seeking a Head of Manufacturing Engineering r to take on the responsibility for managing a team of engineers who provide technical support for on-going plant manufacturing operations in the tissue tech Skin product and Medical Product areas.

Responsibilities:
Ensure that all appropriate documentation, drawings, and specifications are generated in compliance with procedures and statutory requirements (US FDA and ISO)
Perform timely technical investigations and provide practical manufacturing solutions, under appropriate regulatory guidelines for Medical Device manufacturing
Apply experience with manufacturing process equipment to lead the selection and/or design of equipment for prototype and full-scale manufacturing


Qualifications:
8+ years experience in the medical device or pharmaceutical industry
Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, Design Control and Regulatory guidelines is required
Experience managing direct reports (REQUIRED)

For more information about this or other positions please contact Colby Cahill at or

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