Description
We are seeking a highly motivated and skilled Research & Development Engineer to join our dynamic team focused on the design and development of innovative medical devices. This role offers the opportunity to contribute to the full product lifecycle-from concept through to commercialisation-within a regulated, high-impact industry.Key Responsibilities
- Lead and support the design, development, and optimisation of medical devices in accordance with regulatory and quality standards.
- Collaborate cross-functionally with engineering, manufacturing, regulatory, and clinical teams to ensure robust and compliant product development.
- Develop and execute test protocols for design verification and validation.
- Prepare and maintain comprehensive design documentation, including design history files (DHF), risk assessments, and technical reports.
- Participate in design reviews, root cause analysis, and continuous improvement initiatives.
- Ensure compliance with ISO 13485, 21 CFR 820.30, and other relevant standards.
- Bachelor's or Master's degree in Mechanical, Biomedical, Electrical Engineering, or a related discipline.
- Minimum of 3 years of experience in R&D or product development, preferably within the medical device or high-tech manufacturing sector.
- Proficiency in CAD software (e.g., SolidWorks, Creo) and familiarity with prototyping and testing methodologies.
- Strong understanding of design for manufacturability (DFM), usability engineering, and risk management principles.
- Excellent communication, documentation, and project coordination skills.
- Experience working in a regulated environment with knowledge of applicable standards and guidelines.
- The opportunity to work on cutting-edge technologies that improve patient outcomes.
- A collaborative and inclusive work environment that values innovation and integrity.
- Competitive compensation and benefits package.
- Professional development and career growth opportunities.