SUMMARY: This position will develop and implement manufacturing processes, equipment, and fixtures. This role is an integral part of a developmental team in developing and implementing new processes. The ideal candidate has a Bachelor's degree in chemical engineering (polymer chemistry background preferred) and the ability to manage multiple projects within a rapidly changing environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
• Create documentation to support new and improved manufacturing processes
• Write and perform process validations
• Perform IQ/OQ/PQ as required on equipment.
• Disposition NCR’s and CAPA’s as assigned.
• Perform experiments including but not limited to DOE’s to characterize and improve processes.
• Provide leadership and direction for more junior engineers in areas of manufacturing engineering and process development.
• Interface directly with assemblers, production supervisors, leads, engineers, and management on a routine basis.
• Coordinate with the suppliers and external resources needed in developing and implementing new processes.
• Work closely between R&D and Manufacturing to capture and interpret the design intent in order to refine and improve processes.
• Facilitate excellent communications between all team members.

EDUCATION/EXPERIENCE:
• Bachelor degree in chemical engineering or equivalent
• Minimum of two (2) years’ experience, preferably in a medical device environment
• Excellent hands-on communication and interpersonal skills
• Experienced in MS Word, Excel, and Project
• Experience in Design for Manufacturing (DFM), Design of Experiments (DOE) and product/process Failure Mode and Effects Analysis (FMEA).
• Experience with CAD Software (Solid Works & AutoCAD) preferred
• Prior experience in medical device environment preferred
• Supervisory experience preferred

SUPERVISORY RESPONSIBILITIES:

• May oversee work assignments of 1 engineer and/or technician

• Compensation: DOE
• Principals only. Recruiters, please don't contact this job poster.
• Please, no phone calls about this job!
• Please do not contact job poster about other services, products or commercial interests.