Looking On-site || Manufacturing Engineer with Medical Device & Regulations | | Raynham, MA (Onsite)
Role name:
Engineer
Role Description:
Manufacturing Engineer, Foundry, Packaging, Cleanroom, Equipment validation, Process Validation, IQ, OQ, PQ, Product transfer and Manufacturing transfer
Competencies:
EIS : Medical Device & Regulations
Experience (Years):
6-8
Essential Skills:
Manufacturing Engineer - Foundry• Manufacturing Engineer required to support existing and future implant medical device manufacturing lines and systems.• Orthopedic Implants Manufacturing Machinery experience such as Precision Machining Techniques, Design For Manufacturing (DFM) Assistance, Foundry, CNC Milling and Turning, Live Tooling, Surface Finishing (Buffing Process, Electropolishing Process), Laser Marking process, Ultrasonic Cleaning, Sterilization and Packaging.• 3D Printing and Additive Manufacturing Experience• Materials handled Ultra-High Molecular Weight Polyethylene (UHMWPE), Polyetheretherketone (PEEK), Carbon Fiber-Reinforced PEEK.• Daily cleanroom operations and driving a lean, KPI-driven and continuous improvement culture across the department. • 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
Desirable Skills: • Good communication skill,• Has worked in a Packaging, Cleanroom, Equipment machine shop environment (within med device or aerospace preferred)• Product / Manufacturing Transfer activities• Good experience validations (IQ/OQ/PQ)• Understanding of different types of metal/plastic cutting manufacturing processes• Basic understanding of Packaging, clean room, milling and or lathe machines• Understanding of basic Quality systems
Country:
United States
Branch | City | Location:
TCS - Boston, MA
Raynham
Raynham, MA
Keywords:
Manufacturing Engineer, Foundry, Packaging, Cleanroom, Equipment validation, Process Validation, IQ, OQ, PQ, Product transfer and Manufacturing transfer