By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success.
At Integer, our values are embedded in everything we do.
Customer
We focus on our customers’ success
Innovation
We create better solutions
Collaboration
We create success together
Inclusion
We always interact with others respectfully
Candor
We are open and honest with one another
Integrity
We do the right things and do things right
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.
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U.S. Applicants: Equal Opportunity Employer. In addition, veterans and individuals with disabilities are encouraged to apply.
