Design Quality Engineer – MedTech Robotics, Barcelona

Rob Surgical; Barcelona; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Permanent contract

Full-time

Location: Barcelona (DFactory)

Job summary

Rob Surgical in Barcelona seeks a Design Quality Engineer to join our R&D team, shaping how we apply design quality and regulatory controls across product development for a surgical robotic platform. You will collaborate with Mechanical, Electronics, Software and Systems teams to ensure medical device compliance and readiness for regulatory approval.

The role emphasizes design controls, risk management per ISO 14971, and design transfer to manufacturing within an ambitious MedTech company in

Qualifications

• Experience in Design Quality, Design Assurance or R&D Engineering within medical devices.
• Solid knowledge of EU MDR 2017/745, CE marking requirements and the applicable Spanish regulatory framework.
• Familiarity with ISO 13485 and ISO 14971.

Responsibilities

• Integrate design quality principles and regulatory requirements into the R&D process from early development through verification, validation and design transfer.
• Ensure the correct application of design controls throughout the medical device development lifecycle.
• Define and review design inputs, design outputs and acceptance criteria with traceability.
• Identify, assess and mitigate product risks per ISO 14971.
• Support design verification and validation activities to meet intended requirements.
• Ensure engineering activities align with medical device regulations and MDR 2017/745.
• Assess impact of engineering changes on quality, safety, risk management and compliance.
• Collaborate cross-functionally with Mechanical, Electronics, Software, Systems, QA/RA to readiness for regulatory approval.
• Identify opportunities to improve engineering processes and team efficiency.

Job description

Rob Surgical in Barcelona seeks a Design Quality Engineer to join our R&D team, shaping how we apply design quality and regulatory controls across product development for a surgical robotic platform. You will collaborate with Mechanical, Electronics, Software and Systems teams to ensure medical device compliance and readiness for regulatory approval.

The role emphasizes design controls, risk management per ISO 14971, and design transfer to manufacturing within an ambitious MedTech company in