Job Title: Senior Design Assurance Engineer
Job Description
We are seeking a highly skilled and experienced Senior Design Assurance Engineer to join our team. As a key member of our R&D department, you will be responsible for ensuring the design control, risk management, and regulatory compliance of our new product development technologies.
Key Responsibilities:
* Work within the quality system to ensure compliance with relevant regulations, including ISO 13485, ISO 14971, and FDA QSRs.
* Support the development and evolution of design control, risk management, and related systems for new product development technologies.
* Provide design assurance input to R&D project teams, understanding regulatory requirements and incorporating them into projects.
Required Skills and Qualifications
To be successful in this role, you will need to have:
* A degree in Engineering, Science, or a related field.
* Over 5 years of relevant experience in the medical device or pharmaceutical industry.
* Understanding of statistics, validation, and physical testing.
* Good communication and organizational skills, with the ability to present reports clearly and accurately.
Benefits
This is an excellent opportunity to work in a dynamic and growing company, where you will have the chance to develop your skills and expertise in design assurance engineering.
Others
If you are a motivated and experienced individual who is looking for a new challenge, please apply now.