Equipment Engineer 4

Job description

Primary Function of Position

Senior Equipment engineers ensure the efficient and reliable operation of manufacturing equipment used in the production of medical devices. This role involves designing, developing, and maintaining equipment and processes to meet high-quality standards and regulatory requirements. The Senior Equipment Engineer also leads validation activities, troubleshoots technical issues, and collaborates with cross-functional teams to support new product introductions and continuous improvement initiatives.

Additionally, they provide technical expertise and mentorship to junior staff, ensuring the overall effectiveness and compliance of the manufacturing operations.

Essential Job Duties

Design, develop, and implement equipment and processes for manufacturing medical devices. Lead and manage equipment validation activities, including IQ, OQ, and PQ protocols. Troubleshoot and resolve equipment-related issues to ensure minimal downtime and optimal performance. Collaborate with cross-functional teams to support new product introductions and process improvements. Develop and maintain detailed equipment documentation, including specifications, maintenance procedures, and calibration records.

Ensure compliance with regulatory standards (e.g., FDA, ISO) and company quality policies. Provide technical guidance and mentorship to junior engineers and technicians. Conduct risk assessments and implement corrective and preventive actions (CAPA) for equipment-related issues. Manage equipment procurement, installation, and commissioning projects. Monitor and analyze equipment performance data to drive continuous improvement initiatives.

Qualifications

Required Skills and Experience

Technical Expertise: Strong knowledge of equipment design, development, and validation processes, including IQ, OQ, and PQ protocols.

Regulatory Knowledge

Familiarity with regulatory standards such as FDA, ISO 13485, and GMP requirements.

Problem-Solving Skills

Proven ability to troubleshoot and resolve complex equipment-related issues.

Project Management

Experience managing equipment procurement, installation, and commissioning projects.

Documentation Skills

Proficiency in developing and maintaining detailed equipment documentation, including specifications, maintenance procedures, and calibration records.

Analytical Skills

Ability to analyze equipment performance data and implement continuous improvement initiatives.

Communication Skills

Strong verbal and written communication skills for effective collaboration with cross-functional teams and external vendors.

Attention to Detail

High level of accuracy and attention to detail in all aspects of work.Strong communications skills across team organizations and cultures. Must be able to speak, read and write in English 80%. Must be able to travel to the USA.

Required Education and Training

Bachelor’s degree in mechanical engineering, Electrical Engineering, Biomedical Engineering, or a related field (Required). Master’s degree in mechanical engineering, Electrical Engineering, Biomedical Engineering, or a related field (Preferred).

Working Conditions

None Preferred Skills and Experience: Experience: 7-10 years of experience in equipment engineering, with a significant portion in the medical device or pharmaceutical industry.

Leadership

Experience providing technical guidance and mentorship to junior engineers and technicians.

Software Proficiency

Familiarity with CAD software, PLC programming, and other relevant engineering tools. Mid/high volume complex mechanism manufacturing engineering experience preferred. Experienced in ISO 13485, or medical device manufacturing environment.