Job Summary
We are seeking an Associate R&D Engineer to join our team at {company}. This is a unique opportunity for a skilled engineer to contribute to the development of innovative medical devices.
Responsibilities:
* Design and execute Design Verification testing in compliance with GxP regulations.
* Analyze data and create comprehensive test reports.
* Collaborate with cross-functional teams to define evaluation and testing strategies for product/process changes.
* Support regulatory submissions and ensure compliance with relevant regulations.
* Develop and maintain component specifications, protocols, and procedures.
* Investigate product complaints and analyze returned devices to identify root causes.
* Provide support for CAPA and Non-Conformance processes to ensure quality and compliance.
* Contribute to project teams to deliver key objectives, meeting performance, time, and cost targets.
* Liaise with external vendors/resources to achieve project goals.
* Author procedures, protocols, specifications, and reports using strong technical writing skills.
* Understand physician techniques and clinical needs to develop product training materials.
Requirements:
* Bachelor's degree in Mechanical or Biomedical Engineering or equivalent.
* A minimum of 12 months experience in a medical device design or manufacturing environment.
* Strong foundation in engineering principles, including design and technical ability.
* 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.