Senior R&D Engineer
Key Responsibilities:
1. Develop and execute design verification testing plans in a GxP environment to ensure the quality of medical devices.
2. Analyze data and create comprehensive test reports, providing valuable insights for product improvements.
3. Collaborate with cross-functional teams to establish evaluation and testing strategies for product/process changes, ensuring alignment with company goals.
4. Design, develop, and update component specifications, adhering to industry standards and regulatory requirements.
5. Investigate product complaints, analyze returned devices, and implement corrective actions to prevent similar issues in the future.
6. Contribute to project teams to deliver key objectives, meeting performance, time, and cost targets, driving business success.
7. Author procedures, protocols, specifications, and reports, communicating technical information effectively to various stakeholders.
8. Understand physician techniques and clinical needs, assisting in the development of product training materials to enhance user experience.
Requirements:
1. Honours degree in Mechanical or Biomedical Engineering, or an equivalent qualification.
2. Approximately 8 years of experience in a medical device design or manufacturing environment, with expertise in product development and testing.
3. Prior experience working in the design and testing of stents, stent delivery systems, and neurovascular catheters, with a strong understanding of their applications.
4. Knowledge of metals, including Nitinol, Stainless Steel, Platinum, and their applications in medical devices.
5. Working knowledge of FEA, laser cutting/annealing, and treatments of metallic components, with hands-on experience in testing stents and neurovascular devices.
6. Strong technical leadership skills in new product development, with an expert understanding of disease states and creative product solutions.
7. Data review and statistical methods skills, with experience using tools like Minitab.
8. Experience with medical devices, particularly cardiovascular or neurovascular implants, with a strong work ethic and creative problem-solving abilities.