Research and Development Engineer.

Research and Development Engineer Galway, IrelandCompany Overview Our client is a prominent player in the medical device industry, committed to enhancing healthcare globally. Position Overview We are seeking a proficient Research and Development Engineer on a contractor basis to support our Shelf-Life Extension initiative for several commercial products. The ideal candidate will possess Design Control expertise, hands-on experience with Design Verification, and a solid grasp of technical writing. Additionally, familiarity with material properties, ageing impacts, Product Specifications, Test Methods, and regulatory requirements is essential for this role. Key Responsibilities Collaborate closely with cross-functional teams to execute Shelf-Life Extension strategies for commercial products, ensuring compliance with regulatory standards and quality requirements. Develop and execute Design Verification protocols and reports, meticulously documenting findings and ensuring alignment with product specifications. Conduct thorough technical analyses to assess material properties, ageing effects, and potential risks associated with shelf-life extension. Define and execute sample selection processes, considering factors such as sample size, unit rationale, and statistical analyses (variable vs attribute stats). Work closely with Bill of Materials (BOMs), Process Plans, design prints, and design inputs/outputs to drive successful project outcomes. Manage documentation processes, including regulatory submissions, design documentation, and risk management activities. Collaborate with team members to ensure project milestones are met, escalating issues as needed and actively contributing to problem-solving efforts. Demonstrate independence, initiative, and technical proficiency in navigating project complexities and challenges. Qualifications Bachelor's degree in Engineering or related field; advanced degree preferred. Proven experience in Design Control within the medical device industry, with a focus on Shelf-Life Extension projects. Strong familiarity with Design Verification methodologies, including protocol development, execution, and report writing. Excellent technical writing skills, with the ability to communicate complex concepts clearly and effectively. In-depth understanding of material properties, ageing processes, and their implications for product performance and shelf-life extension. Knowledge of Product Specifications, Test Methods, and statistical analyses (sample selection, variable vs attribute stats). Proficiency in interpreting and working with Bill of Materials (BOMs), Process Plans, design prints, and design inputs/outputs. Familiarity with Risk Management processes and regulatory requirements (e.g., ISO 13485, FDA regulations). Ability to work independently, seek guidance when necessary, and collaborate effectively within a team environment.