As an R&D engineer working in the medical device and pharmaceutical industry, your main duties will involve conducting research, development, and implementation of new medical devices and pharmaceutical products that comply with industry regulations and standards. Some of your key responsibilities may include:
Product development: Creating and designing new medical devices and pharmaceutical products, taking into account regulatory guidelines, user requirements, and industry standards.
Design control: Developing and maintaining design control documentation, such as Design History Files, Bill of Materials, and Technical Master Files, to ensure compliance with regulations like EUMDR and FDA.
Risk management: Conducting risk assessments, creating and executing risk management plans for medical devices and pharmaceutical products, and identifying and mitigating potential risks.
Testing and validation: Performing testing and validation of medical devices and pharmaceutical products, including writing and executing protocols for test method validation and establishing release test criteria.
Regulatory compliance: Ensuring all product development activities adhere to applicable regulatory standards and guidelines such as EUMDR and FDA.
Collaboration: Working with other engineers, scientists, and technicians to achieve project goals and communicating research findings and recommendations effectively to management and other stakeholders.
Continuous improvement: Continuously monitoring and improving existing products and processes, keeping up with industry trends and emerging technologies to drive innovation and improvements.
Root cause analysis: Conducting root cause analysis of non-conformance or deviations and implementing corrective and preventive actions.
Your specific responsibilities may vary depending on your organization and project, but as an R&D engineer in this industry, you will play a critical role in developing safe, effective, and high-quality medical devices and pharmaceutical products that improve patient outcomes.