Spearhead Design Assurance Initiatives
As a Senior Design Assurance Engineer, you will be instrumental in driving the development of cutting-edge technologies within our organization. Your expertise will play a pivotal role in shaping our product offerings and ensuring they meet rigorous regulatory standards.
Main Responsibilities:
* Collaborate with cross-functional teams to implement design control processes and risk management strategies that foster a culture of innovation and compliance.
* Deliver high-quality design assurance input to R&D project teams, leveraging your extensive knowledge of regulatory requirements to drive successful product launches.
* Develop and execute comprehensive test methodologies to validate product designs, ensuring seamless integration with existing systems.
Requirements:
* Bachelor's degree in Engineering, Science, or a related field from an accredited institution.
* Minimum 5 years of experience in the medical device or pharmaceutical industry, with a proven track record of delivering results in fast-paced environments.
* Thorough understanding of ISO standards and FDA QSRs, with the ability to apply this knowledge to drive process improvements and ensure regulatory compliance.