Manufacturing engineer

Position Summary
Responsible for designing, implementing and optimizing manufacturing processes during the construction, qualification, and start-up phases of the new plant. Acts as the technical focal point between equipment engineering, quality, production and suppliers, ensuring processes are ready for stable, safe and regulatory-compliant production from day one.

Key Responsibilities
- Participate in plant layout and process flow design alongside the engineering/construction team.
- Define and document manufacturing processes, including process sheets, work instructions and technical specifications.
- Lead or support equipment qualification (IQ/OQ/PQ) and process validation.
- Coordinate with equipment suppliers on installation, commissioning and technical training.
- Identify and resolve process issues during the ramp-up phase, applying continuous improvement methodologies (Lean, Six Sigma).
- Collaborate with Quality and Regulatory to ensure compliance with ISO 13485, FDA 21 CFR 820 and other applicable medical device regulations.
- Establish process performance indicators (OEE, scrap, cycle times) and monitoring systems from start-up.
- Train operators and technicians on new processes and equipment.
- Support the selection and implementation of automation systems where applicable.
- Own preventive and corrective maintenance of plant equipment once in operation, ensuring machine uptime, reliability, and compliance with maintenance schedules.
- Work closely with the EEE team in Mexico to coordinate operational training on machine use and maintenance procedures, ensuring knowledge transfer for both operators and technical staff.

Requirements
- Industrial, Mechanical, Electromechanical, Mechatronics Engineering or related field.
- 5?7 years of manufacturing experience, preferably in medical devices, pharma, or another regulated industry.
- Prior experience in greenfield start-ups or process transfers is a plus.
- Knowledge of process validation (IQ/OQ/PQ) and ISO 13485 quality systems.
- Experience with preventive/corrective maintenance programs
- Manufacturing; Advanced English (written and spoken) ? regular communication with headquarters/regional team.
- Strong problem-solving skills, ability to work in a multidisciplinary team, and adaptability to the fast-changing environment typical of a greenfield project.