Manufacturing Engineer

Position's Scope
Responsible for driving the transition of complex, multidisciplinary medical devices from design to sustainable serial production thru ECO process, as well as sustaining and optimizing active manufacturing lines. The scope encompasses process design, yield optimization, system-level troubleshooting (mechanics, electronics), and strict adherence to medical device quality regulations (ISO 13485 / FDA 21 CFR Part 820).
Skills
BOM maintenance & PLM:
High proficiency in drafting technical documents, Standard Operating Procedures (SOPs), and navigating Product Lifecycle Management (PLM) systems for bill of materials (BOM) management.
Multidisciplinary Troubleshooting:
Strong systems-level diagnostic skills to root-cause failures occurring at the intersection of mechanical, electrical, or firmware subsystems.
Validation & Risk Management:
Practical proficiency in writing and executing validation protocols (IQ/OQ/PQ, TMV) and conducting risk analysis (pFMEA)
Education
B.Sc. in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or Manufacturing Engineering from an accredited institution.
Relevant Experience
Minimum of 2+ years of experience as a Manufacturing/Production Engineer within Medical Devices industry
Proven track record of executing Engineering Change Orders (ECOs) within a structured Quality Management System (QMS).
Advantage Experience
Direct experience collaborating with external contract manufacturers (CMs) and suppliers on component and system level quality issues.
Familiarity with Arena and Priority systems
Subordinate to:
Engineering Director

Work arrangement
Yes