Prototype Engineer

Job Title: Operations Officer - Prototyping

Job Summary

The Operations Officer - Prototyping will work closely with the design and development teams to support the realization of innovative medical device prototypes. This role involves hands-on fabrication, coordination with external vendors, maintenance of internal prototyping equipment, and ensuring that prototypes are developed efficiently and meet specified technical and quality standards in line with requirements.

Responsibilities

Collaborate with engineers and designers to understand prototype requirements and specifications.

Fabricate and assemble prototypes using various manufacturing methods (e.g., 3D printing, machining, manual assembly).

Operate, maintain, and calibrate internal prototyping equipment including 3D printers, Equipments, machines, laser cutters, etc.

Source materials, tools, and components necessary for prototype fabrication.

Coordinate with external vendors for specialized fabrication, machining, and procurement activities.

Manage prototype build schedules to align with overall project timelines.

Document prototype fabrication processes, modifications, and testing results accurately.

Support design verification and validation activities through prototype testing assistance.

Ensure compliance with internal SOPs and quality system requirements (ISO 13485).

Implement improvements in prototype processes to enhance quality, speed, and cost-effectiveness.

Maintain a safe, organized, and efficient prototyping lab environment.

Skills Required

Strong hands-on skills in mechanical fabrication, assembly, and troubleshooting.

Proficiency in operating prototyping and fabrication equipment (e.g., hand tools).

Basic understanding of mechanical and electrical systems related to medical devices.

Familiarity with reading and interpreting engineering drawings and schematics.

Vendor management and material sourcing skills.

Basic knowledge of design for manufacturability (DFM) and prototyping best practices.

Good documentation and reporting abilities.

Effective communication and teamwork skills.

Ability to work independently under minimal supervision.

Awareness of medical device development regulatory and quality standards (ISO 13485) is an advantage.

Educational Qualifications

Diploma in Mechanical Engineering, Biomedical Engineering, Industrial Design, or a related technical field.

Certification or technical training in fabrication, machining, or prototyping techniques is a plus.

Experience

4+ years of hands-on experience in a prototyping, fabrication, or technician role.

Prior experience in the medical device industry or a regulated industry is highly desirable.