Manufacturing Engineer
Please Share resume to sagar.bhardwaj@diverselynx.com
Role: Manufacturing Engineer – Foundry
Location: Raynham, MA (Onsite)
Job Description:
Manufacturing Engineer, Foundry, Packaging, Cleanroom, Equipment validation, Process Validation, IQ, OQ, PQ, Product transfer and Manufacturing transfer
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
Regards
Sagar Bhardwaj
Sr. Technical Recruiter
300 Alexander Park |Suite #200|Princeton , NJ 08540
Office: +1 7324521006 Ext238
Email: sagar.bhardwaj@diverselynx.com| URL: http://www.diverselynx.com
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