Manufacturing Engineer

Position Responsibilities:

• Maintains and improves procedures, documentation, tools, fixtures, and programs on existing printed circuit boards, electro-mechanical assemblies, and final products.
• Identify the root cause of manufacturing process and product nonconformities. Identify and implement the necessary actions to correct and prevent recurrence though the corrective and preventative action process.
• Participates with Product Development engineering in the creation/modifying of test programs to verify the performance to specification of new assemblies, peripherals, and products.
• Responsible for the maintenance of production test programs upon release to production.
• Responsible for diagnosing and investigating technical problems and resolving problems or developing solutions. Work in conjunction with other departments where appropriate.
• Generate and execute Process Validation protocols and continuously improve manufacturing documentation.
• Trains technicians on production methods, equipment, and procedures for new and existing assemblies and products.
• Improve Operations Quality System Processes to meet local and Corporate Quality initiative goals.

Education Required: • B.A./B.S. in Electrical Engineering, Manufacturing Engineering, Industrial Engineering or BioMedical Engineering.

Years Of Experience: • 2+ years of experience in a manufacturing support role

Specialized Knowledge Required: • Statistical knowledge; DOE, SPC, etc.

• Ability to read and work with technical drawings and/or electrical schematics.
• Experience in Windows applications including Microsoft Office.
• Experience in FDA 21 CFR Part 820 Medical Device Manufacturing.

Preferred Qualifications: • Master’s Degree preferred.

• Familiar with the FDA’s Design Control process, and ISO requirements.
• Experience in automated testing using LabView,Test Stand or similar software.
• Knowledge of x-ray equipment and/or other capital equipment.
• Familiarity with Lean Manufacturing, and Six Sigma.

If interested and want to apply, please contact:

Ebrahim Sayarwala

ebrahim.sayarwala(at)collabera.com

973-854-9128