Associate R&D Engineer
Responsibilities:
1. Plan and execute Design Verification testing in a GxP environment.
2. Perform data analysis and test reporting.
3. Collaborate on defining evaluation and testing strategies for product/process changes.
4. Support regulatory submissions.
5. Create and/or update component specifications.
6. Investigate product complaints and analyze returned devices.
7. Provide support for CAPA and Non-Conformance processes.
8. Contribute to the project team to deliver key objectives, meeting performance, time, and cost targets.
9. Liaise with external vendors/resources to achieve project goals.
10. Write procedures, protocols, specifications, and reports.
11. Understand physician techniques and clinical needs to develop product training materials.
12. Perform other duties as required.
Requirements:
1. Honours degree in Mechanical or Biomedical Engineering or equivalent.
2. Approximately 12 months experience in a medical device design or manufacturing environment.
3. Design and technical ability based on fundamental engineering principles.
4. Data review and statistical methods skills (e.g., Minitab).
5. High level of technical writing and reporting skills.
6. Strong work ethic, creative problem-solving, and capable of working on own initiative.
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