Job Duties :       

Support project management, existing device design and new product development design activities. Ensures that combination product development and process validation activities are compliant with quality and regulatory standards. Provide test method development and validation as well as technical support for new product development of combination products and new processes in manufacturing for pharmaceutical/medical devices. Support process, design controls and component improvements projects. Evaluate, manage, and report the process capability of the equipment and services employed in the operation. Manage supplier technical audits and corporate audits. Apply technical knowledge of Operations, Quality, Validation, etc. along with internal/external business challenges to provide input into recommendations for product development and improvements. Lead multi-functional project teams through high technical risk assessments and complex engineering/technology solution development.

Requirements:       

Master’s degree or foreign equivalent in Engineering (Process, Mechanical) or closely related manufacturing science field plus 2 years of experience in the job offered or related product/process engineering development positions. Must have experience in product management, process validation (IQ/OQ/PQ), and test method development and validation (ASTM) of medical devices within the pharmaceutical industry. Must have experience with cGMP and GLP, Design Controls, QSR, QMS and Risk Management Regulations/Standards used for FDA and ISO.

Travel required to various unanticipated locations throughout the US.

Apply:

Recruitment – SunTechPros

5920 S. Miami Blvd, Suite 205-B
Morrisville, NC  27560

OR

Apply at www.suntechpros.com.

Must reference  “Device Engineer” when applying.