Website Macpower Digital Assets Edge Private Limited
Macpower Digital Assets Edge Private Limited
Company : Macpower Digital Assets Edge Private Limited
Job Overview:
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 (phone number removed) and (phone number removed) 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
Must Have Skills, Experience:
Equipment Validation Expertise: Must have experience in overseeing the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes to ensure equipment meets required standards.
Regulatory Compliance Knowledge: Must have a strong understanding of FDA regulations (21 CFR Part 820, Part 807, Part 830) and ISO standards (ISO (phone number removed) & (phone number removed), especially in the medical device industry.
Quality Control Experience: Must have hands-on experience with quality control systems, including monitoring, inspection, and testing to maintain high product standards.
Packaging and Cleanroom Familiarity: Must be familiar with cleanroom protocols, medical device packaging processes, and environmental control requirements.
Tool Design and Fabrication: Must have in-depth knowledge of tool design and fabrication methods, especially in metal and plastic cutting manufacturing processes.
Manufacturing and Product Transfer Experience: Must have experience managing manufacturing and product transfers, ensuring smooth and efficient scaling of production processes.
Project Management Skills: Must have strong project management abilities, including the planning, coordination, and execution of manufacturing engineering initiatives.
Mechanical and Biomedical Engineering Background: Must have a solid background in mechanical, manufacturing, or biomedical engineering to address technical challenges and solutions.
Equipment Maintenance and Troubleshooting: Must be capable of maintaining and troubleshooting critical equipment-systems to ensure smooth manufacturing operations.
Problem-Solving Abilities: Must have strong problem-solving skills to analyze and resolve complex manufacturing issues in a timely and efficient manner.
Safety and Environmental Standards Awareness: Must have a good understanding of safety regulations and environmental standards in a manufacturing environment.
Excellent Communication Skills: Must possess excellent communication skills to collaborate effectively with cross-functional teams and document processes and findings clearly.