Device Development Leader
5 days ago
Why Work with Us
We offer a dynamic and supportive work environment that fosters growth and development. As a Device Development Leader, you will have the opportunity to lead high-impact projects and contribute to the development of innovative medical devices.
About the Role
This role involves managing all aspects of engineering projects and product verification activities to ensure timely completion within budget. You will plan and conduct verification projects using existing or new scientific methods, theories, and applicable engineering practices.
Key Responsibilities
- Manage project timelines, resources, and budgets to ensure successful project delivery.
- Develop and implement execution plans for completing verification activities, monitor progress, and take action to resolve problems.
- Define test specifications, develop test protocols & reports, devise test methods, analyze test results, and prepare reports in compliance with regulatory requirements and product specifications.
- Ensure accurate documentation of deviations, investigations, and countermeasures as required.
- Coordinate and facilitate the transfer of test specifications and test methods to cross-functional teams as needed to support design transfer activities.
Requirements
- Minimum Bachelor's Degree in engineering; preferable in Mechanical, Biochemical, Chemical, or Manufacturing.
- At least 3 years of working experience in product design verification and validation.
- Experience in Solidworks/CAD and familiarity with jigs and fixtures is an advantage.
- Experience in conducting test method validation and root cause analysis.
- Strong analytical and quantitative skills in statistical analysis.
- Experience in product reliability testing, ISO13485, and product design control according to FDA is an advantage.
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