Research and Development Engineer

Research and Development Engineer
Galway, Ireland

Company 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.