Pursue Your Passion with Purpose
MDA Edge
Manufacturing Engineer
Manufacturing Engineer, Foundry, Packaging, Cleanroom, Equipment validation, Process Validation, IQ, OQ, PQ, Product transfer and Manufacturing transfer.
Good communication.
Has worked in a Packaging, Cleanroom, Equipment machine shop environment (within med device or aerospace preferred).
Understanding of different types of metal/plastic cutting manufacturing processes.
Understanding of basic Quality systems.
Need to have good knowledge of tool design and fabrication methods.
This position will involve overseeing the maintenance and calibration of critical equipment-systems.
Other necessary manufacturing engineer skills include project management ability, commitment to quality, and familiarity with safety and environmental standards.
Hands on experience in Quality Control and Regulatory Compliance in Implant Manufacturing.
Experience in FDA Regulations and ISO Standards: 21 CFR, Quality system regulation (Part 820), establishment registration (Part 807), and unique device identification (Part 830). ISO 11607-1 and 11607-2 updates require usability studies for medical device packaging.
The candidate should have a strong background in manufacturing, mechanical, production, biomedical engineering or other related disciplines.
6+ years of Working Experience machine shop environment.
Vacancy posted 4 days ago
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