R&D Risk and Usability Engineer

An exciting opportunity awaits for a R&D Risk and Usability Engineer in Penang, where your expertise will directly contribute to the advancement of healthcare technology.

This role is perfect for those who are passionate about ensuring the safety, effectiveness, and user-friendliness of medical devices through rigorous risk analysis and usability engineering. You will be joining a globally recognised organisation with a long-standing reputation for excellence in medical technology, offering you the chance to work within a supportive hybrid working model. With access to comprehensive training programmes, education assistance, and robust retirement benefits, this position provides not only professional growth but also personal well-being. If you are ready to make a meaningful impact on global health while developing your career in an inclusive and collaborative environment, this is the ideal next step.

• Be part of a renowned international medical technology leader with a strong presence across Asia Pacific, providing stability and significant opportunities for career progression.
• Enjoy flexible hybrid working arrangements in Penang, along with access to extensive training, education support, and long-term benefits such as retirement schemes and medical insurance.
• Contribute to the future of healthcare by ensuring that innovative medical devices meet the highest standards of risk management and usability engineering.

What you'll do:

As a R&D Risk and Usability Engineer based in Penang, you will play an essential role in shaping the safety profile of innovative medical devices. Your day-to-day responsibilities will involve applying up-to-date industry standards across all R&D projects while establishing robust SOPs that guide teams from ideation through production launch. You will be instrumental in evaluating existing procedures for compliance, supporting continuous improvement efforts that keep products at the forefront of quality assurance. By implementing sophisticated risk management frameworks—including FMEA and FTA—you will help identify potential issues early in the development process. Your ability to plan formative and summative evaluations ensures that every device meets stringent usability requirements before reaching patients. Working collaboratively with cross-functional teams spanning design, engineering, regulatory affairs, and quality assurance will allow you to integrate best-in-class risk management practices into every stage of product development. Staying informed about regulatory changes enables you to prepare meticulous documentation for audits or submissions. Success in this role means proactively safeguarding patient safety while driving innovation forward within a highly respected global organisation.

• Apply and monitor relevant industry standards, reviewing and analysing new or amended regulations to ensure ongoing compliance throughout R&D activities.
• Establish, implement, and oversee standard operating procedures (SOPs), utilising advanced systems and tools to support project management within R&D initiatives.
• Evaluate development processes, documentation, and records to guarantee alignment with daily practices while supporting the creation of SOPs from initial concept through to production start-up.
• Implement comprehensive risk management strategies and conduct detailed product risk analyses with a focus on usability engineering and human factors integration.
• Plan, design, and execute complex risk management tasks using both established methodologies and innovative approaches tailored to specific project needs.
• Conduct thorough risk analyses including Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA), ensuring timely delivery of all risk management outcomes.
• Coordinate formative and summative evaluations by preparing prerequisite documents, identifying necessary supplements, and tracking progress alongside cross-functional teams such as design, engineering, regulatory affairs, and quality assurance.
• Integrate risk management principles seamlessly into the product development lifecycle by collaborating closely with various departments to enhance overall product safety and usability.
• Stay abreast of evolving industry standards, regulations, and best practices related to risk management and usability engineering to maintain cutting-edge knowledge within the field.
• Prepare comprehensive documentation required for regulatory submissions and audits, ensuring accuracy, completeness, and readiness for external review.

What you bring:

To excel as a R&D Risk and Usability Engineer in this setting, you will bring proven experience from roles focused on quality assurance or engineering within the medical device industry. Your background should include hands-on involvement with risk assessment methodologies such as FMEA or FTA as well as practical exposure to usability engineering principles. A solid grasp of international standards like ISO 14971:2019 or IEC 62366-1:2020 will underpin your ability to ensure compliance at every stage of product development. Your written English must be exemplary—enabling you to produce precise documentation—while your verbal communication skills help foster understanding among colleagues from different disciplines. Persuasiveness allows you to advocate effectively for best practices during collaborative projects involving design engineers or regulatory specialists. Experience preparing materials for audits or regulatory bodies highlights your meticulous approach; meanwhile your enthusiasm for continuous professional development keeps your knowledge base current amid changing regulations. Above all else, your dedication to teamwork ensures that collective goals are achieved efficiently while maintaining high standards of patient safety.

• Bachelor’s degree in Science or Engineering is required as foundational academic preparation for this technical role.
• A minimum of two years’ experience in a related field or within Quality Engineering/Management specifically in the medical device sector is essential for success.
• Demonstrated expertise in methodological compliance for Risk & Usability Methods throughout Medical Device Development & Lifecycle-Management is highly valued.
• Comprehensive knowledge of ISO 14971:2019 standard for application of risk management to medical devices is expected.
• Familiarity with IEC 62366-1:2020 regarding application of usability engineering to medical devices is important for effective performance.
• Understanding FDA Guideline for Human Factors 2016 as well as broader medical device regulations supports your ability to navigate complex compliance landscapes.
• Outstanding written English skills are necessary for preparing clear documentation; strong communication abilities enable effective collaboration across teams.
• Persuasive interpersonal skills facilitate consensus-building among diverse stakeholders during cross-functional projects.
• Experience preparing documentation for regulatory submissions or audits demonstrates attention to detail critical in this environment.
• A commitment to ongoing learning ensures you remain current with evolving industry standards relevant to risk management and usability engineering.

What sets this company apart:

This organisation stands out as one of the world’s most respected names in medical technology—a legacy built over nearly two centuries with operations spanning more than sixty countries. The Penang site serves as both regional headquarters for Asia Pacific operations and a Centre of Excellence for intravenous access solutions. Employees benefit from being part of one of Malaysia’s largest manufacturing hubs dedicated exclusively to medical products—offering unparalleled exposure to advanced technologies used worldwide. The company’s commitment extends beyond business success: it invests heavily in employee well-being through retirement benefit schemes, long service awards recognising loyalty over time, comprehensive medical insurance plans safeguarding health needs, structured training programmes designed for skill enhancement at every career stage, plus education assistance initiatives supporting lifelong learning ambitions. The workplace culture emphasises inclusivity—valuing contributions from all backgrounds—and encourages collaboration across functions so everyone can share knowledge freely while growing together professionally. Joining this team means becoming part of an organisation where your work truly matters: improving lives globally by delivering safe effective healthcare solutions every day.

What's next:

If you are inspired by the prospect of advancing healthcare through expert risk management and usability engineering—and want your contributions recognised within a supportive global network—this is your moment!

Apply today by clicking on the link provided or email me at TengHong.Khoo@robertwalters.com.my to discuss this new opportunity!

Take the next step towards making a lasting difference in healthcare innovation.

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C