ENG

About the Role

We are looking for a motivated Design Control Junior Engineer to join our growing R&D; team in the medical device sector. This position offers an exciting opportunity to contribute to the development of innovative Class III medical devices while working within a highly regulated environment.

The successful candidate will support design control activities throughout the product lifecycle, including requirements definition, risk management, verification and validation, usability engineering, and regulatory compliance.

Key Responsibilities
- Define User Needs and User Requirements based on customer feedback, Voice of Customer (VoC), and market requirements.
- Generate and manage Design Inputs, specifications, and traceability matrices.
- Support product development projects to ensure compliance with customer, technical, and regulatory requirements.
- Participate in design verification and validation activities for new and existing products.
- Develop and review test methods, protocols, and reports.
- Contribute to risk management activities, including DFMEA, PFMEA,



and usability-related risk assessments.
- Collaborate with cross-functional teams, including Engineering, Quality, Regulatory Affairs, and Clinical stakeholders.
- Support maintenance of product risk management files throughout the product lifecycle.
- Participate in change control activities and failure investigations.
- Support validation activities, including EO sterilization validation.
- Monitor applicable standards and regulations related to medical devices, biocompatibility, packaging, sterilization, and risk management.

Qualifications

Required
- Bachelor's degree in Biomedical Engineering or a related engineering discipline.
- 1-2 years of experience in a similar role, internship, or trainee position.
- Strong analytical and problem-solving skills.
- Excellent attention to detail.
- Ability to work independently and within multidisciplinary teams.
- Good written and verbal com

📌 Design Control Junior (Sant Quirze del Vallès)
🏢 Anaconda Biomed
📍 Sant Quirze del Vallès