R&D Engineer

R&D Engineer

PROCHEM Engineering

Waterford, Ireland

Role Purpose:

• Our client is seeking a highly motivated R&D Engineer to join the Research and Development Team based at their busy pharmaceutical facility in Co. Waterford.
• This role involves supporting the development and optimisation of new and existing products, processes, and technologies within the client’s advanced ophthalmic portfolio.
• The successful candidate will contribute to innovative projects while ensuring compliance with industry standards and collaborating with cross-functional teams.

Core Duties and Responsibilities:

• Assist in the design, development, and testing of new products and processes in alignment with R&D objectives.
• Conduct research and feasibility studies for new product concepts.
• Support validation and verification activities for new technologies and manufacturing processes.
• Apply engineering principles and analytical tools to troubleshoot technical challenges and improve product performance.
• Work closely with cross-functional teams, including Quality, Manufacturing, Regulatory, and Supply Chain, to facilitate product development.
• Prepare and maintain technical documentation, including design specifications and test reports.
• Participate in process improvements and contribute to continuous innovation initiatives.
• Ensure all R&D activities comply with Good Manufacturing Practices (GMP), ISO 13485, and FDA regulations.
• Stay informed on industry trends, emerging technologies, and regulatory requirements related to medical devices.

Education & Qualifications Required:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related technical field.
• Minimum 0 – 2 years of experience in an R&D Engineering role within the medical device, pharmaceutical, or healthcare industry (internship experience considered).
• Basic knowledge of product development life cycle, design controls, and regulatory standards (ISO 13485, FDA 21 CFR Part 820).
• Familiarity with CAD software (e.g., SolidWorks, AutoCAD) and simulation tools is desirable.
• Understanding of materials science, polymer processing, and manufacturing technologies for medical devices.
• Strong analytical skills, problem-solving abilities, and willingness to learn statistical analysis tools.
• Effective communication and teamwork skills to collaborate with various departments.
• Ability to manage tasks efficiently and work in a dynamic environment.
• Exposure to ophthalmic or contact lens technology is a plus.
• Understanding of Design for Six Sigma (DFSS) and Lean Manufacturing principles is an advantage.
• Basic knowledge of process validation (IQ, OQ, PQ) and statistical process control (SPC) preferred.
• Interest in regulatory submissions and technical documentation for medical devices.

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