Information Technology Engineer; Senior Manufacturing Engineer - Medical Device Equipment

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

• 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.