Senior Product Designer Broadview Heights, - OH - Ohio

Title Plastic Product Design Engineer Location:

Broadview Heights,OH Duration:

Contract Plastic Product Design Engineer is responsible for the design, development, validation, and manufacturing support of plastic components used in medical devices. This role ensures that plastic parts meet stringent regulatory, quality, safety, and biocompatibility requirements, while supporting cost-effective and reliable high-volume production. Relevant Experience (in Yrs) 2 4 years TechnicalFunctional Skills Strong analytical and problem-solving skills Excellent documentation and technical writing skills High attention to detail and compliance mindset Ability to work cross-functionally in regulated product development teams Clear communication with suppliers, auditors, and internal stakeholders Experience Required Strong understanding of polymer science and medical-grade plastic materials Hands-on knowledge of injection molding and precision molding processes Experience working in a regulated medical or life-sciences manufacturing environment Familiarity with quality systems and validation documentation Experience in Class I, II, or III medical device manufacturing Knowledge of cleanroom manufacturing practices (ISO Class 78) Experience with biocompatibility, extractables, and chemical resistance Experience using CADCAE tools (SolidWorks, Creo, CATIA, Moldflow) Exposure to combination products and drug-device integration Roles & Responsibilities Design and develop plastic components and sub-assemblies for medical devices, disposables, and drug-delivery systems Select medical-grade plastic materials (USP Class

VI, ISO 10993

compliant) based on performance, sterilization, and regulatory requirements Support and review mold design for injection molding, micro-molding, insert molding, and multi-shot molding Develop, optimize, and validate plastic manufacturing processes following IQOQPQ requirements Ensure compatibility of plastic components with sterilization methods (EtO, Gamma, E-beam, Steam) Conduct root cause analysis and troubleshooting for molding defects, dimensional issues, and cosmetic defects Collaborate closely with Quality, Regulatory, R D, Tooling, and Manufacturing teams Support design control activities including DFMEA, PFMEA, risk management, and design reviews Ensure compliance with FDA (21 CFR Part 820), ISO 13485, ISO 14971, and customer regulatory standards Support new product introduction (NPI) and design transfer to manufacturing Manage supplier development activities for toolmakers and plastic part suppliers Prepare and maintain technical documentation such as DMRs, DHRs, process flow diagrams, and validation reports Education Minimum B.S. degree from an ABET-accredited school (or global equivalent) in one of the following engineering disciplines, 2-4 years of experience: Bachelor s degree in Plastics Engineering, Polymer Engineering, Mechanical Engineering, or a related field. Medical devices, particularly the Orthopedic industry, experience preferred.