Client is looking for 2 Manufacturing Engineer for a 6 plus month contract or a temp to perm. Must work onsite in Marlborough MA. Solidworks AND Plastics are required BSME
Master’s degree or equivalent in related scientific or engineering fields (mechanics, micro- mechanics).
Minimum 8 year-experience in designing, developing and manufacturing plastic disposable kit products for regulated industry (medical device, class II and/or class III).
Well-founded knowledge and practical experience of relevant regulations (ISO13485, FDA 21 CFR Part 820), specifically for the US and European market product submission.
Proficiency in using SolidWorks modeling 3D CAD design software and FEA experience with ANSYS or equivalent applications. PDM experience is a plus.
Strong organizational and communication skills.
Experience in performing product verifications activities (protocol, test execution, report).
Experience in manufacturing processes development associated with a medical device or biological application is a strong asset (e.g. rapid prototyping technologies, injection molding, compression molding, tube extrusion, thermoforming, heat staking, ultrasonic welding, laser welding, snap-fitting, UV gluing, solvent bonding).
Knowledge of plastic biocompatibility, leachable & extractable and sterilization techniques is a plus.
