Biomedical Engineer

San Sebastián, Spain            ·              Full time

Title: Biomedical Engineer

Description

We are looking for a Biomedical Engineer who will work together with the head of the company’s Regulatory Affairs & QA department.

This is an excellent opportunity for an experienced professional to put their talent, skills and experience to work in a young, high potential startup dedicated to improving people’s lives.

The candidate will have a high degree of freedom to put their talents into practice while learning from experienced colleagues and joining a team currently composed of more than 15 people and with a strong network of external collaborations.

Requirements

• University education in engineering (preferably biomedical engineering) or health sciences.
• Proactive, organised and methodical profile.
•  English: fluent conversation (B2 level).
•  Internship experience in the area of Quality and Regulatory Affairs (ideally with the medical device sector) in one of the following areas will be a plus:
  •  European regulations on medical devices (EU 2017/745), ISO 13485 quality management systems, or standards: ISO 14971, ISO 14155, MEDDEV and FDA guidelines.
• Identify, design and implement the company’s processes in terms of product quality, safety and efficiency.
• Verify that the technical documentation and the EU and American declaration of conformity are drafted and updated.
• Manage reporting obligations and ensure compliance of medical devices with the quality management system in the manufacturing process.
• Strengthen and intensify relationships with clinical teams in order to improve processes.
• Detect system risks that affect internally or external collaborators.
• Constant dialogue with suppliers, regulatory authorities (Spanish and international), medical staff.

What we offer?

• Joining a cutting-edge technology startup offering disruptive medical solutions.
• Professional development opportunities
• Interesting financial conditions

Apply

If you have any doubt related to this position, please send us an email toinfo@denebmedical.com

Please click here to apply.