R&D Engineer II

R&D Engineer II

Integer

Galway, Ireland

Job Summary:

We are seeking a talented and motivated R&D Engineer II to join our dynamic Research & Development team in Galway. In this role, you will play a crucial part in developing innovative medical devices that improve patient care and advance healthcare technology. You will collaborate with cross-functional teams to design, prototype, and test new products, ensuring they meet regulatory standards and industry requirements.

Job Responsibilities:

• Product Development: Design, develop, and prototype new medical devices and improve existing products using engineering principles and methodologies.
• Research & Innovation: Conduct research to identify new technologies and materials that can enhance product performance and meet clinical needs.
• Testing & Validation: Develop and execute testing protocols to verify and validate product designs, ensuring compliance with regulatory standards (e.g., FDA, ISO 13485).
• Documentation: Maintain detailed documentation of design control, risk management activities, and test results in accordance with quality management systems.
• Collaboration: Work closely with cross-functional teams, including engineering, sales, quality assurance, design assurance, and regulatory affairs, to ensure successful project outcomes.
• Regulatory Compliance: Ensure all products meet safety, functionality, and performance specifications, adhering to relevant regulatory requirements.
• Process Improvement: Identify opportunities for process improvements and implement solutions to enhance efficiency and product quality.
• Stakeholder Engagement: Collaborate with customers, suppliers, and vendors to deliver project goals.

Education & Experience:

• Minimum Level 8 degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or a related field.
• Minimum of 2 years’ industry experience with research & development experience in medical device considered an advantage.

Skills and Knowledge:

• Strong understanding of engineering principles and medical device development processes.
• Excellent problem-solving and analytical skills.
• Ability to work collaboratively in a team environment and communicate effectively with diverse stakeholders.
• Knowledge of statistical techniques and tools (e.g., DoE, Six Sigma, Minitab) is an advantage.
• Proficiency in 2D and 3D CAD modeling.
• Commitment to quality, safety, and regulatory compliance.
• Experience with design verification and validation, including familiarity with regulatory standards (e.g., FDA, ISO 13485).
• Experience with CAD software (e.g., SolidWorks) and other engineering tools.