ROBOTIMIZE Hiring! Full Time Product - Regulatory Engineer in Federal Territory - Ricebowl

Company: Robotimize

Position: Product & Regulatory Engineer

Employment: Full-time

Location: Malaysia

Reports to: Product & Technical Lead

About Robotimize

Robotimize is a rehabilitation technology company focused on bringing innovative rehabilitation and assistive technologies, including rehabilitation robotics, into clinical practice. The company develops its own rehabilitation technologies while also working with selected international technology and manufacturing partners.

Robotimize works across the product lifecycle, from product development and engineering through regulatory compliance, commercialisation, installation, training and ongoing technical support. As the company expands its product portfolio and regional presence, we are seeking a Product & Regulatory Engineer to strengthen our engineering, technical documentation, regulatory and service capabilities.

Role Purpose

The Product & Regulatory Engineer will develop and maintain the engineering and technical documentation required to support Robotimize products throughout their lifecycle, from product development and regulatory approval through deployment, servicing and continuous improvement.

The role combines hands-on product engineering with regulatory and technical documentation, providing an opportunity for an early-career engineer to develop broad expertise across the medical-device product lifecycle.

This is an early-career position, and fresh graduates are encouraged to apply. Previous medical-device or regulatory experience is advantageous but is not essential. Training and guidance will be provided.

We are particularly looking for someone who is dedicated, responsible and methodical, with strong attention to detail and a natural inclination to maintain accurate, complete and well-organised technical documentation.

Key Responsibilities

• Product Engineering: Develop and maintain a strong technical understanding of Robotimize products; support product development, testing, verification and validation, engineering changes and continuous product improvement; and work with manufacturers and suppliers on technical and product-quality matters.

• Regulatory & Technical Documentation: Develop and maintain complete, accurate and well-organised technical and regulatory documentation, including product technical files, specifications, risk-management documentation, verification and validation records, labelling and instructions for use; and support regulatory submissions and responses to regulatory requirements.

• Service & Technical Support: Develop and maintain service procedures, technical instructions and records; provide engineering support for installation, commissioning, troubleshooting and servicing; and support the Service Technician in resolving technical issues and feeding field experience back into product improvement.

• Cross-functional Support: Provide technical support to the commercial, clinical and marketing teams, including product information, demonstrations, exhibitions, installations and other customer-facing activities where engineering input is required.

Qualifications & Experience

A Bachelor's degree in a relevant engineering discipline, such as Mechatronics, Mechanical, Biomedical, Electrical/Electronic Engineering, or another related field.

The position is suitable for fresh graduates or engineers in the early stages of their careers. Previous experience in medical devices, rehabilitation technology, regulatory affairs, quality systems, technical documentation or product development would be advantageous but is not required.

Candidates should have sound engineering fundamentals and an interest in developing practical knowledge across engineering, medical devices and regulatory requirements.

Skills & Personal Attributes

For this position, we place particular importance on the individual's attitude, discipline and capacity to learn. The successful candidate should be:

• Dedicated and responsible, with a strong sense of ownership and willingness to see work through to completion.

• Highly attentive to detail, with the patience and discipline required to produce accurate technical and regulatory documentation.

• Organised and methodical, taking pride in maintaining neat, complete and traceable documents and records.

• A clear communicator with good written and spoken English, particularly for preparation of technical documents and communication with international manufacturers and partners.

• Technically curious, with good engineering fundamentals and an interest in understanding how products work.

• Comfortable with both hands-on engineering work and detailed documentation.

• Able and willing to learn medical-device regulatory requirements, standards and quality processes.

• Able to work independently while communicating effectively and seeking guidance when required.

• Cooperative and comfortable working across engineering, clinical, commercial and operational activities in a growing company.

Key Working Relationships

The Product & Regulatory Engineer will work closely with the Product & Technical Lead and Group General Manager, as well as Robotimize's engineering, clinical/product, commercial and service personnel.

The role will also interact regularly with external manufacturers and suppliers, regulatory consultants, testing laboratories, service providers and other technology partners.

Development Opportunity

This position is intended to provide a strong development pathway for a young engineer. The successful candidate will gain exposure to the complete lifecycle of rehabilitation and medical technology products—from engineering and product development through technical documentation, regulatory processes, deployment, servicing and continuous improvement.

As experience develops, the engineer will be expected to take increasing ownership of products, technical files, regulatory activities and engineering projects.

Robotimize is looking for someone who wants to grow with the company, develop broad technical and regulatory capability, and progressively take on greater responsibility as the company's product portfolio and regional activities expand.