MD
Information Technology Engineer (Senior Manufacturing Engineer - Medical Device Equipment)
Macpower Digital Assets Edge Private Limited
🇺🇸 United States
On-site
Senior
5 days ago
$34 / hour
- Foundry
- calibration
- Regulatory Compliance
5 days ago
- 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
- 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 11607-1 & 11607-2), 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.
Information Technology Engineer (Senior Manufacturing Engineer - Medical Device Equipment) · Macpower Digital Assets Edge Private Limited