Process Engineer

Process Engineer

At Anaconda Biomed we are seeking a motivated Process Engineer to develop optimize validate and transfer manufacturing processes for innovative medical devices.

You will help scale and improve manufacturing processes support technology transfers from R&D to Production lead continuous improvement initiatives and ensure compliance with quality and regulatory requirements.

Experience in a regulated environment is required with preference for candidates from the Medical Device industry or the pharmaceutical biotechnology or healthcare sectors.

An advanced level of English is required both written and spoken. English is regularly used for internal and cross-functional meetings international collaboration training and technical documentation.

• Design develop optimize and validate manufacturing processes.
• Support technology transfers from R&D to Production.
• Analyze process performance and identify improvement opportunities.
• Define control and monitor critical process parameters.
• Design and execute process characterization studies and Design of Experiments (DoE).
• Support process validation and equipment qualification.
• Investigate deviations and non-conformities and support corrective and preventive actions.
• Collaborate with Production Quality R&D Regulatory Affairs and Supply Chain teams.
• Prepare and maintain technical documentation in line with Quality Management System requirements.
• Support continuous improvement projects using Lean Manufacturing Kaizen TPM and 5S methodologies.
• Define monitor and analyze KPIs related to quality efficiency and process performance.
• Support the implementation commissioning and optimization of new manufacturing equipment and technologies.
• Ensure compliance with internal procedures and applicable regulatory requirements.

• Bachelors degree in Mechanical Industrial Biomedical or Chemical Engineering or a related field.
• Experience in manufacturing or industrial environments.
• Experience supporting process improvement and manufacturing optimization projects.

Preferred Qualifications

• Experience in the Medical Device industry.
• Experience working under regulated quality systems such as ISO 13485 GMP or equivalent.
• Experience in medical devices pharmaceuticals biotechnology healthcare or another highly regulated sector.
• Experience with process validation and equipment qualification.
• Experience managing CAPAs non-conformities and change controls.
• Practical experience with Lean Manufacturing and continuous improvement methods.
• Experience with Design of Experiments (DoE) and statistical analysis.

• Process optimization and manufacturing process control.
• Process validation principles.
• Analytical and statistical techniques.
• CAD tools preferably SolidWorks or similar software.
• Lean Manufacturing Kaizen TPM and 5S methodologies.
• Quality management systems and regulated documentation.

Spanish and English Advanced level required (C1 or equivalent)

You should be comfortable with:

• Participating in internal and cross-functional meetings in English.
• Attending and contributing to training sessions in English.
• Communicating with international teams and global stakeholders.
• Drafting and reviewing technical documentation in English.

You understand the importance of quality traceability documentation and regulatory compliance in daily operations.

Experience in medical device companies or other regulated environments is highly valued particularly experience with process validation document control change management regulatory compliance and quality systems.

The ideal candidate combines a strong engineering background a continuous improvement mindset effective communication skills in English and experience working within the quality standards and regulatory requirements of highly regulated industries.