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Information Technology Engineer (Senior Manufacturing Engineer - Medical Device Equipment)

Macpower Digital Assets Edge Private Limited

Raynham, MA

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JOB DETAILS
SALARY
$34–$34 Per Hour
SKILLS
Aerospace and Defense, Analysis Skills, Biomedical Engineering, Calibration, Cleanroom, Code of Federal Regulations, Communication Skills, Control Systems, Cross-Functional, Engineering, Equipment Maintenance/Repair, Equipment Validation, FDA Requirements, ISO (International Organization for Standardization), Identify Issues, Implants, Information Technology & Information Systems, Machining, Manufacturing, Manufacturing Engineering, Manufacturing Management, Manufacturing Operations, Manufacturing/Industrial Processes, Mechanical Engineering, Medical Equipment, Medical Protocols, Metal Cutting, Plastics Manufacturing, Problem Solving Skills, Process Validation, Product Management, Project/Program Management, Quality Control, Regulations, Regulatory Compliance, Safety Standards, Safety/Work Safety, Team Player, Testing, Time Management, Usability Engineering
LOCATION
Raynham, MA
POSTED
13 days ago
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 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
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 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.

About the Company

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Macpower Digital Assets Edge Private Limited

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