R&D Engineer II ( Parkmore East Galway)

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.

Responsibilities

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

Education & Experience

Minimum Level8 degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or a related field. Minimum of 2years' industry experience with research and development experience in medical devices considered an advantage.

Skills & 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.

Equal Opportunity Employment

Integer Holdings Corporation is an equal opportunity employer. All employment decisions are based only on valid job requirements. No discrimination based on race, color, sex, religion, national origin, disabled veteran status, or any other protected characteristic. Veterans and individuals with disabilities are encouraged to apply.