Job description for Assistant Engineer Position

About The Role

We are seeking a motivated and detail-oriented Assistant Engineer to support the production and development of wound care products within a regulated medical device environment. The successful candidate will work closely with the engineering and management teams across multiple functions, including product development, facility management, production operations, and QMS documentation.

This role is well-suited for candidates holding a Diploma in Mechanical Engineering, Materials Science, Biomedical Engineering, or related disciplines, with or without prior additive manufacturing experience. On-the-job training will be provided.

Key Responsibilities:

Production & Product Development

· Assist in the manufacturing and processing of wound care products according to approved procedures.

· Support manufacturing, designing and engineering activities as required.

· Conduct basic testing, inspection, and recording of process and product data.

Quality & Compliance

· Draft and maintain documentation within the Quality Management System (QMS) in line with ISO 13485 and regulatory requirements.

· Perform in-process checks and maintain accurate batch records, logs, and reports.

· Assist in the preparation of validation and verification activities (IQ/OQ/PQ, risk assessments, etc.).

· Support audits and compliance reviews by ensuring proper recordkeeping and document control.

Facility & Equipment Management

· Monitor and support day-to-day operations of the cleanroom facilities.

· Assist in scheduling, calibration, and preventive maintenance of production and test equipment.

· Ensure compliance with safety, cleanliness, and environmental standards (ISO 7/8 cleanroom, chemical handling, workplace safety etc.).

Cross-Functional Support

· Provide administrative and technical support for projects as assigned by management.

· Participate in continuous improvement initiatives to enhance efficiency and compliance.

Qualifications & Skills

· Diploma in Mechanical, Materials, or Biomedical Engineering, or related engineering field.

· Fresh graduates are welcome; prior experience in manufacturing, additive manufacturing (FDM/FFF), or medical device production is advantageous but not mandatory.

· Familiarity with quality systems (ISO 13485, GMP) is a plus.

· Strong attention to detail, good documentation practices, and organizational skills.

· Ability to work in a regulated cleanroom environment.

· Proficient in Microsoft Office (Excel, Word, PowerPoint).