Job Description

Join our dynamic Manufacturing & Supply Chain team and play a key role in developing, optimizing, and sustaining world-class manufacturing processes for life-changing medical devices. We're looking for an innovative, hands-on engineer who thrives in a regulated environment and enjoys driving continuous improvement across cross-functional teams.

Let's Talk About the Role:

Lead the design, development, and optimization of manufacturing processes for Class I, II, and III medical devices. Ensure full compliance with ISO 13485, MDSAP, FDA QSR, GMP, and other relevant regulatory standards. Work closely with R&D, Quality, Regulatory, and Operations to ensure new products are manufacturable, scalable, and cost-effective. Develop and execute process validation protocols (IQ/OQ/PQ) and support risk management activities such as PFMEA. Design fixtures, tooling, and production layouts using AutoCAD, SolidWorks, and other CAD tools. Drive Lean, Six Sigma, and SPC initiatives to improve process capability, efficiency, and yield. Use data analytics to monitor performance, identify trends, and drive decisions using tools such as Excel, Minitab, Python, or Power BI. Investigate and resolve manufacturing issues through structured root cause analysis and corrective actions. Support cleanroom operations and ensure adherence to environmental and GMP requirements. Lead capital equipment selection, installation, qualification, and performance verification. Build business cases to support process improvements and capital investments. Plan and manage engineering project budgets, timelines, and deliverables. Mentor junior engineers and provide guidance to cross-functional teams. Support internal and external audits and maintain readiness for MDSAP criteria.

Let's Talk About You:

Bachelor's or Master's degree in Mechanical, Biomedical, Manufacturing Engineering, or related discipline. Minimum 2 years of experience in medical device manufacturing or a regulated industry. Proficiency in AutoCAD/SolidWorks and CAD-based design for manufacturing. Strong knowledge of ISO 13485, MDSAP, FDA QSR, and GMP. Experience in process validation, statistical analysis, and technical documentation. Skilled in data analytics using Excel, Minitab, Python, Power BI, or similar tools. Understanding of cleanroom manufacturing and sterile production environments. Strong problem-solving, communication, and project management skills.

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Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.