Job Description:
We are seeking a talented and motivated R&D Engineer to join our dynamic Research & Development team. 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.
Key Responsibilities:
* Product Development: Design, develop, and prototype new medical devices 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).
* Documentation: Maintain detailed documentation of design control, risk management activities, and test results in accordance with quality management systems.
* Cross-Functional Collaboration: Work closely with 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.
Requirements:
* Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or related field.
* Minimum 2 years' industry experience with research & development experience in medical device considered an advantage.
* 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.