Senior R&D Engineer

Azon recruitment is delighted to partner with a leading global manufacturer of medical devices to recruit for a Senior R&D Engineer for their Enniscorthy site.

In this role, you’ll collaborate across departments to spearhead research and development initiatives for intricate medical devices. Your focus will be the design, crafting, and deploying of products, whilst emphasising chemistry advancement, project management, innovative design, and rigorous testing.

Key Responsibilities:

• Conceptualise, develop, and implement products and procedures for medical devices, transforming abstract design concepts into tangible engineering specifications and blueprints.
• Lead and contribute to multidisciplinary teams in medical device design, fostering idea generation and potentially contributing to intellectual property submissions.
• Pioneer new chemical solutions for medical devices and facilitate the transition of chemical processes to production readiness.
• Innovate new processes by comprehending pivotal inputs and outputs, employing statistical methods like Design of Experiments (DOE) where applicable.
• Design new process equipment and tooling, from specification creation to vendor selection and negotiation.
• Draft and review comprehensive product development plans, technical documents, and reports.
• Develop and validate verification and validation protocols and reports, along with implementing relevant procedures and policies.
• Establish new engineering and clinically relevant test methodologies, collaborating with R&D technicians and aiding in method validation.
• Conduct engineering assessments and competitor analyses, alongside unit testing during development.
• Strategise, execute, and oversee verification and validation activities for emerging products and processes.
• Provide training for technicians and engineers on new design, process development, and test methodologies.
• Mentor and guide R&D technicians and engineers through the intricacies of New Product Development projects.
• Offer support across Manufacturing, Quality, Regulatory, and R&D to ensure adherence to internal and external standards.
• Lead or assist in design and process root cause analyses, and contribute to investigations of non-conforming products and complaints.

Responsibilities:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related field.
• 6-9 years of industry experience in R&D or process development, ideally within a regulated FDA/QSR and ISO environment.
• Demonstrated hands-on technical proficiency.
• Experience in chemistry or chemical engineering.
• Proficiency in process validation (Installation Qualification, Operational Qualification, Performance Qualification), including protocol and report composition and execution. Capability to devise and execute project plans.
• Leadership aptitude for guiding cross-functional teams.
• Fundamental understanding of tooling, design, and drafting.
• Outstanding verbal and written communication skills.
• Ability to analyse data, interpret findings, and produce comprehensive reports, with proficiency in statistical software.

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