Associate R&D Engineer

Associate R&D Engineer

Responsibilities:

• Plan and execute Design Verification testing in a GxP environment.
• Perform data analysis and test reporting.
• Collaborate on defining evaluation and testing strategies for product/process changes.
• Support regulatory submissions.
• Create and/or update component specifications.
• Investigate product complaints and analyze returned devices.
• Provide support for CAPA and Non-Conformance processes.
• Contribute to the project team to deliver key objectives, meeting performance, time, and cost targets.
• Liaise with external vendors/resources to achieve project goals.
• Write procedures, protocols, specifications, and reports.
• Understand physician techniques and clinical needs to develop product training materials.
• Perform other duties as required.

Requirements:

• Honours degree in Mechanical or Biomedical Engineering or equivalent.
• Approximately 12 months experience in a medical device design or manufacturing environment.
• Design and technical ability based on fundamental engineering principles.
• Data review and statistical methods skills (e.g., Minitab).
• High level of technical writing and reporting skills.
• Strong work ethic, creative problem-solving, and capable of working on own initiative.

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