Manufacturing Engineer at EPM Scientific

Job Description:

Latest job information from EPM Scientific for the position of Manufacturing Engineer. If the Manufacturing Engineer vacancy in Barcelona matches your qualifications, please submit your latest application or CV directly through the updated Jobkos job portal.

Please note that applying for a job may not always be easy, as new candidates must meet certain qualifications and requirements set by the company. We hope the career opportunity at EPM Scientific for the position of Manufacturing Engineer below matches your qualifications.

Contract Opportunity: Manufacturing Engineer - Medical Devices (ISO 13485)

Location: Barcelona, Spain

Contract Duration: 12 months

Start Date: Immediate

Engagement Type: Freelance / B2B / Temporary Employment

A leading medical device manufacturer is seeking an experienced Manufacturing Engineer to support advanced production operations in compliance with ISO 13485 and EU MDR standards. This is a 12-month contract role based in Barcelona, offering the opportunity to contribute to the development and scale-up of Class II and III medical devices in a regulated, high-performance environment.

Role Overview

The successful candidate will be responsible for the design, validation, and optimization of manufacturing processes, ensuring full compliance with applicable regulatory frameworks. The role requires close collaboration with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, and Supply Chain.

Key Responsibilities

• Develop, implement, and validate manufacturing processes for new and existing medical devices.
• Lead process characterization, risk analysis (PFMEA), and control strategy development.
• Prepare and execute IQ/OQ/PQ protocols for equipment and process validation.
• Support design transfer activities and ensure readiness for commercial manufacturing.
• Drive continuous improvement initiatives using Lean Manufacturing and Six Sigma methodologies.
• Ensure full documentation and traceability in accordance with ISO 13485, FDA 21 CFR Part 820, and EU MDR.
• Collaborate with suppliers to ensure component quality and process capability.
• Provide technical support for non-conformance investigations and CAPA implementation.

Candidate Profile

• Degree-qualified in Mechanical, Biomedical, or Manufacturing Engineering (BSc/MSc).
• Minimum 5 years of experience in medical device manufacturing within an ISO 13485-compliant environment.
• Demonstrated expertise in process validation, equipment qualification, and cleanroom operations.
• Strong working knowledge of GMP, FDA QSR, and EU MDR requirements.
• Proficiency in CAD software, statistical analysis tools (e.g., Minitab), and ERP/MES systems.
• Fluent in English; proficiency in Spanish is advantageous.

Preferred Qualifications

• Six Sigma Green or Black Belt certification.
• Experience with Class III implantable devices or high-volume disposables.
• Familiarity with automation, robotics, and Industry 4.0 technologies.

Offer

• Competitive daily rate.
• Opportunity to work on innovative, life-saving technologies.
• Support with relocation logistics if required.
• Collaborative and international working environment.

Job Info:

• Company: EPM Scientific
• Position: Manufacturing Engineer
• Work Location: Barcelona
• Country: ES

How to Submit an Application:

After reading and understanding the criteria and minimum qualification requirements explained in the job information Manufacturing Engineer at the office Barcelona above, immediately complete the job application files such as a job application letter, CV, photocopy of diploma, transcript, and other supplements as explained above. Submit via the Next Page link below.