(Junior Biomedical Engineer)

Opus; Riyadh; On-site; SAR 120,000 - 180,000; Full time

Job summary

Opus in Riyadh is seeking a Medical Devices R&D Engineer to lead development of advanced medical devices, design prototypes, and run tests from concept to launch.

The role emphasizes compliance with quality and safety standards, regulatory requirements for medical devices, and collaboration with quality, production, and marketing teams. English documentation is required.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Medical Devices Engineering, or related field.
• Experience in R&D for medical devices and product design.
• Proficiency with engineering design software (SolidWorks, AutoCAD).

Responsibilities

• Quality & Reliability: perform routine quality tests on devices before sale and inspect factory samples against specs.
• Technical Inspection & Failure Analysis: inspect customer returns, conduct tests on electronic, mechanical, and optical components, classify failures.
• Technical Support & After-Sales: provide support to customer service, train staff, prepare user manuals and FAQs, assist with warranty cases.

Skills

Research skills

Analytical thinking

Problem solving

Innovation

Education

Bachelor’s degree in Biomedical Engineering, Medical Devices Engineering, or related

Tools

SolidWorks

AutoCAD

Job description

Job Purpose

Contribute to ensuring the quality of laser devices and personal care devices, support technical inspection and failure analysis processes, and provide internal and external technical support to ensure that products comply with quality and safety standards.

Key Tasks and Responsibilities

First: Quality & Reliability

• Perform routine quality tests on devices before approving them and putting them up for sale.
• Inspect samples received from factories and ensure they meet the approved technical specifications.
• Participate in preparing and updating inspection lists (Checklists) and quality standards.
• Document the results of technical tests and issue quality reports.
• Monitor failure indicators and technical complaints, and analyze their root causes.
• Contribute to implementing continuous improvement procedures to enhance product quality.
• Verify that products meet safety requirements and safe use requirements.

Second: Technical Inspection and Failure Analysis

• Inspect devices returned by customers and identify the causes of failures.
• Conduct technical tests for electronic, mechanical, and optical components.
• Classify failures by type (manufacturing, operational, improper use, transport and shipping).
• Prepare technical reports that explain the cause of the failure and the proposed corrective action.
• Follow up on recurring failures and submit recommendations to the technical management and the factory.
• Create a database of approved failures and technical solutions.

Third: Technical Support and After-Sales Service

• Provide technical support to the customer service team regarding technical inquiries.
• Train customer service staff on the basics of the devices and how to handle common malfunctions.
• Prepare user manuals and frequently asked technical questions (FAQ).
• Support customers in resolving complex technical issues when needed.
• Coordinate with maintenance centers or suppliers to resolve special technical cases.
• Technically follow up on warranty and replacement cases

Medical Devices R&D Engineer

Tasks and Responsibilities:

• Research and develop new medical devices and products, and improve existing products.
• Design prototypes and conduct the necessary technical tests and trials.
• Study market needs and translate them into technical requirements and specifications.
• Analyze test results and identify opportunities to improve device efficiency and quality.
• Prepare and update technical documentation and design and development files.
• Collaborate with quality, production, and marketing teams to develop and launch products.
• Ensure that products comply with quality and safety standards and regulatory requirements for medical devices.
• Research modern technologies, materials, and solutions used in the manufacture of medical devices.
• Follow up on product development stages from the idea through manufacturing and launch.
• Prepare technical reports and document the results of research and trials.

Requirements:

• Bachelor’s degree in Biomedical Engineering, Medical Devices Engineering, or a related specialization.
• Experience of at least two years in research and development in the field of medical devices.
• Experience in product design, preparing prototypes, and executing tests.
• Knowledge of regulatory requirements and medical device standards, such as ISO 13485 and ISO 14971.
• Proficiency in using engineering design software, such as SolidWorks or AutoCAD.
• Strong research, analysis, problem-solving, and innovation skills.
• Ability to prepare technical documents and reports in English.
• Preference for experience in registering medical products with the Saudi Food and Drug Authority.