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.
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