Process Engineer (Injection Moulding Specialist)On-siteEngineering (Production/Process Dev/Manufacturing)Our client, a leader in developing, qualifying, and commercializing innovative drug delivery systems and biomedical products based in Dublin, is looking for a Process Engineer (Injection Moulding Specialist) to join the team.
As a Process Engineer specializing in Injection Molding, you will play a key role in developing, optimizing, and scaling high-precision injection molding processes for biomedical and medical device clients.
Responsibilities include but are not limited to: Develop, configure, and optimize injection molding processes to achieve optimal quality, efficiency, and scalability for medical devices and drug delivery systems.Oversee design of experiments (DOE) to refine and validate injection molding processes, ensuring compliance with industry standards and regulatory requirements.Implement process controls and robust quality assurance practices, utilizing methods like Statistical Process Control (SPC) and Design for Manufacturing (DFM).Conduct and document Failure Modes and Effects Analysis (FMEA) to anticipate and mitigate potential risks in the injection molding process.Analyze and resolve process deviations and product defects using root cause analysis, collaborating with quality and production teams to drive corrective actions.Recommend and implement process improvements, focusing on lean manufacturing principles, cost efficiency, and waste reduction.Collaborate with R&D, engineering, quality, and manufacturing teams to ensure alignment between product design, process requirements, and manufacturing capabilities.Lead projects to qualify new molds, materials, and equipment for production, working closely with suppliers and external partners.Develop and maintain comprehensive documentation for molding processes, validation protocols, and standard operating procedures (SOPs).Report process performance metrics and project milestones to the client's leadership and relevant stakeholders.Job RequirementsRequirements: Bachelor's degree in Mechanical Engineering, Chemical Engineering, Materials Science, or a related field.3-5 years of experience in injection molding, particularly in a medical device or regulated manufacturing environment.Proficiency in injection molding process development, mold design, and process troubleshooting.Familiarity with industry-standard equipment, polymer materials, and molding techniques, with a strong emphasis on precision and high-quality output.Knowledge of regulatory standards for medical devices (e.g., ISO 13485) and experience with validation and verification processes.
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