Job Title: Senior Design Assurance Engineer
About the Role
We are seeking a highly skilled and experienced Senior Design Assurance Engineer to join our team. As a key member of our engineering department, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.
Key Responsibilities:
* Develop and implement design control processes to ensure compliance with regulatory requirements;
* Lead risk management activities for projects and design changes;
* Design, develop, and validate test methods to support development programs;
* Develop and maintain design verification and validation plans, protocols, and reports;
* Support R&D in preparing and delivering design reviews and checklists;
Requirements
To be successful in this role, you will need to have a degree in Engineering, Science, or a related field, and over 5 years of relevant experience in the medical device or pharmaceutical industry. You should also have a strong understanding of ISO 13485, ISO 14971, and FDA QSRs, as well as good communication and organizational skills.
Skills and Qualifications:
* Bachelor's degree in Engineering, Science, or a related field;
* Over 5 years of experience in the medical device or pharmaceutical industry;
* Strong understanding of ISO 13485, ISO 14971, and FDA QSRs;
* Good communication and organizational skills;
Why Work With Us?
We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced engineer looking for a new challenge, we would love to hear from you.