Equipment Engineer (Medical Devices)

RecruitPedia Pte Ltd; Região Norte; On-site; BRL 150,000 - 210,000; Full time

Job summary

RecruitPedia Pte Ltd. is seeking an Equipment Engineer (Extrusion / Medical Device) to drive automation, process optimisation and validation in a high-volume manufacturing setting in the North region of Brazil.

The role requires 5–8 years of experience in medical device manufacturing, with strong CAD/DOE skills and a track record in process validation and regulatory compliance such as GMP and ISO 13485. You will lead equipment technicians, oversee safety and participate in training across sites.

Qualifications

• Degree in Engineering or related technical discipline.
• 5–8 years in high-volume manufacturing.
• Experience in medical device manufacturing, catheter production is a plus.
• Proficient in CAD, DOE, SPC, and control charts.
• FMEA, IQ/OQ, MVP, TMV protocols experience.

Responsibilities

• Develop, implement and optimise manufacturing processes to improve productivity and reduce manual intervention while maintaining product quality.
• Design and develop production tools, jigs, fixtures and assembly methods to support new product introductions and manufacturing improvements.
• Identify automation opportunities, troubleshoot equipment and process issues, and implement solutions to improve production efficiency and output.
• Lead process, equipment and material validation activities, including qualification protocols, testing and documentation.
• Ensure manufacturing processes comply with GMP, ISO 9001, ISO 13485 and regulatory requirements.
• Evaluate new manufacturing technologies and assess their technical feasibility and cost-effectiveness.
• Supervise Equipment Technicians and support workplace safety, incident investigations and corrective actions.
• Support overseas training at the designated sending site and perform rotating shifts, including evening and night shifts.

Skills

CAD

DOE

Statistical methods

Process validation

GMP/ISO knowledge

Education

Engineering degree

Job description

Our client is a leading medical device manufacturer specialising in the development and production of medical catheter products. Due to business needs, they are now recruiting a Equipment Engineer (Extrusion / Medical Device) to drive manufacturing automation, process optimisation and validation activities for ongoing production operations. They are located in the North - easily accessible.

Responsibilities:

• Develop, implement and optimise manufacturing processes to improve productivity, reduce manual intervention and maintain product quality.

• Design and develop production tools, jigs, fixtures and assembly methods to support new product introductions and manufacturing improvements.

• Identify automation opportunities, troubleshoot equipment and process issues, and implement solutions to improve production efficiency and output.

• Lead process, equipment and material validation activities, including qualification protocols, testing and documentation.

• Ensure manufacturing processes comply with applicable quality systems and regulatory requirements, including ISO 13485, GMP and FDA standards.

• Evaluate new manufacturing technologies and assess their technical feasibility, cost-effectiveness and potential operational benefits.

• Supervise Equipment Technicians and support workplace safety, incident investigations and corrective actions.

• Support overseas training at the designated sending site and perform rotating shifts, including evening and night shifts, as required.

Requirements:

• Degree in Engineering or a related technical discipline, with 5–8 years of experience in a high-volume manufacturing environment.

• Medical device manufacturing experience, particularly in catheter production, will be an advantage.

• Proficient in CAD software, Design of Experiments (DOE), statistical methods, process capability analysis and control charting.

• Experienced in process validation and qualification documentation, including FMEA, MVP, IQ/OQ and TMV protocols.

• Knowledge of GMP, ISO 9001, ISO 13485 and medical device regulatory requirements.

We regret that only shortlisted candidates will be notified.