Manufacturing Engineer

Job/Position Summary

5+ years experience in Electrical or Mechanical engineering or equivalent

Exp in NPI/Advance Eng and On-Market product documentation

Exp in working manufacturing floor and capture documentation details

Change analysis/change order (ECN/ECO/CA/CO , etc) creation and track through approval process

IQ/OQ/PQ documentation and execution

Electrical OR mechanical Drawing edit (CAD Drawing in Solid works, Schematics in Altium/OrCAD) Solid works OR equivalent

Support Process Validation, Equipment / Fixture Qualification and Component Qualification activities

Process quality system documentation, Standard Operating Procedures (“SOPs”), manufacturing instructions as well as other types of documentation releases such as DHFs.

Component obsolescence management as needed

Good understanding on medical standards and medical product development life cycle

Familiarity with J&J process is plus

Manage design history files process by: reviewing and releasing on the Agile System Certificates, Design Reviews, BOM, Confidential Documents, Protocols, Validations, Verifications, Purchase Request for Parts, Test Reports, Software Documents, and Technical files