Associate R&D Engineer
Responsibilities:
1. Develop and execute Design Verification testing protocols in compliance with GxP regulations.
2. Analyze data, generate reports, and communicate findings to stakeholders.
3. Collaborate on strategy development for product and process changes, ensuring alignment with regulatory requirements.
4. Support preparation of regulatory submissions, including documentation and review.
5. Establish and maintain component specifications, adhering to industry standards.
6. Investigate product complaints, analyzing returned devices to identify root causes.
7. Provide technical assistance for Corrective Action and Preventive Action (CAPA) processes.
8. Contribute to project teams, delivering key objectives within defined performance, time, and cost parameters.
9. Engage with external partners and vendors to achieve project goals.
10. Develop and maintain procedures, protocols, and reports, ensuring clarity and accuracy.
11. Prioritize understanding of physician techniques and clinical needs to create effective product training materials.
12. Perform additional tasks as required by the role.
Requirements:
1. Bachelor's degree in Mechanical or Biomedical Engineering, or equivalent qualification.
2. A minimum of 12 months' experience in medical device design or manufacturing environments.
3. Demonstrated expertise in design and technical principles, underpinned by fundamental engineering knowledge.
4. Proficiency in data analysis and statistical methods, including software such as Minitab.
5. Excellent technical writing and reporting skills, enabling clear communication of complex ideas.
6. Strong work ethic, coupled with creative problem-solving abilities and a willingness to work independently.