Description
Responsibilities:- Work with cross-functional team to ensure design control procedures are followed during software development. Ensure compliance with ISO 13485, ISO 14971, and EN 62304.
- Develop, maintain, and ensure compliance with software development procedures.
- Assist in the development of software requirements specifications, design specifications, validation plans, and traceability matrices. Ensure DHF meets regulatory requirements.
- Participate in risk analysis and risk-based testing for medical device.
- Participate in product design reviews.
- Ensure validation of Off-the-Shelf software used in the software development process.
- Support audit process.
QUALIFICATIONS
- Must have at least 5 years of experience with software quality engineering within the medical device industry.
- Must have a solid understanding of Quality System Regulations, ISO 13485, ISO 14971, and EN 62304.
- Experience with 510(k) or PMA process.
- Solid understanding of the software development process.
- Strong working knowledge of quality performance metrics.
- Working knowledge of software programming.
- Experience with Visure Requirements (IRQA) and LDRA preferred.
- Excellent communication and documentation skills.
- Excellent problem solving skills.
- B.S. in computer science or other related field.
To find out more about Real please visit www.realstaffing.com