Our client, a leader in developing, qualifying, and commercializing innovative drug delivery systems and biomedical products based in Dublin, are 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.
Responsiblities 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.
Requirements:
* 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.
Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.
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