Design Quality Engineer

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

Help us shape the future of robotic surgery.

At Rob Surgical, we are developing innovative robotic technology to improve surgical precision and patient outcomes.

We are looking for a Design Quality Engineer to join our R&D team in Barcelona. You will work closely with our engineering teams to ensure that product design and development meet the quality, safety and regulatory requirements applicable to medical devices.

This is a hands-on engineering role at the intersection of product development, design quality and regulatory compliance, helping bring our surgical robotic platform to market.

What will you do?

• Design Quality: Integrate design quality principles and regulatory requirements into the R&D process, from early development through verification, validation and design transfer.
• Design Controls: Ensure the correct application of design controls throughout the medical device development lifecycle.
• Requirements Management: Work with engineering teams to define and review design inputs, design outputs and acceptance criteria, ensuring consistency and traceability.
• Risk Management: Collaborate with engineers to identify, assess and mitigate product risks throughout the design and development process, in accordance with ISO 14971.
• Verification & Validation: Support the planning and review of design verification and validation activities to ensure that the product meets its intended requirements.
• Regulatory Compliance: Ensure that engineering activities align with applicable medical device regulations and standards, including the EU Medical Device Regulation (MDR 2017/745) and relevant Spanish legislation.
• Design Changes: Assess the impact of engineering changes on product quality, safety, risk management and regulatory compliance.
• Cross-functional Collaboration: Work closely with Mechanical, Electronics, Software and Systems Engineering teams, as well as QA/RA, to address design quality challenges and support product readiness for regulatory approval and commercialization.
• Continuous Improvement: Identify opportunities to improve engineering processes, design quality practices and team efficiency.

What are we looking for?

• A degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering or a related technical discipline.
• Experience in Design Quality, Design Assurance or R&D Engineering within the medical device industry.
• Solid knowledge of the EU MDR 2017/745, CE marking requirements and the applicable Spanish regulatory framework.
• Practical understanding of design controls and their application throughout the medical device development lifecycle.
• Familiarity with ISO 13485 and ISO 14971.
• Experience with risk management, design verification and validation, requirements traceability and engineering change processes.
• Strong analytical and problem-solving skills, with the ability to work directly with engineers on complex technical challenges.
• A proactive, hands-on mindset and the ability to collaborate effectively in a multidisciplinary R&D environment.
• Professional proficiency in English and Spanish.

Nice to have:

• Experience with active medical devices, complex electromechanical systems or surgical robotics.
• Interest in and awareness of emerging AI tools and their potential applications in engineering and product development, with a proactive approach to identifying opportunities to improve processes, workflows and efficiency.

Why join Rob Surgical?

• Meaningful impact: Contribute to technology designed to improve patient outcomes and advance surgical care.
• Cutting-edge engineering: Work on an innovative surgical robotic platform alongside a multidisciplinary R&D team.
• Ownership and impact: Play an active role in integrating design quality into engineering decisions and product development.
• A pivotal stage of growth: Join a MedTech company transitioning towards commercialization, where your contribution will have a direct impact.
• Innovation-driven environment: Be part of a team that values continuous learning, collaboration and the exploration of new technologies.

What we offer?

• Location: DFactory, Barcelona, Spain.
• Contract: Permanent contract (indefinite-term).
• Working hours: Full-time.
• Salary: Based on experience and qualifications.

If you are passionate about engineering, medical device design and regulatory compliance, and want to contribute to the development of next-generation surgical robotics, we would love to hear from you. Join us in shaping the future of robotic surgery.