Job description
We are seeking a seasoned Senior Development Engineer to join Intersurgical Medical Sdn Bhd, located in Bukit Minyak, Penang. In this pivotal role, you will lead the end-to-end development of new medical devices and major product changes from concept through design, testing, and production readiness. You will own the technical strategy, deliver robust design solutions, and work with cross-functional teams to drive safe, reliable, and scalable products to market.
As a key member of the R&D and operations ecosystem, you will champion design controls, risk management (FMEA), and documentation to ensure compliance with ISO 13485 and regulatory requirements. You will plan and oversee verification and validation activities, including test protocol development, reliability testing, environmental qualification, and design transfer to manufacturing. Your leadership will help reduce risk, improve product performance, and shorten time to market.
You will collaborate with QA, Regulatory, Manufacturing, Supply Chain, and Corporate R&D to translate concepts into manufacturable products, optimize processes, and support post-launch improvements. The role also involves mentoring junior engineers, leading design reviews, and driving continuous improvement initiatives to achieve quality, cost, and schedule targets.
If you are a proactive problem-solver with a strong engineering foundation, excellent communication skills, and a passion for improving patient outcomes, this is your opportunity to contribute to life-changing devices with Intersurgical.
In addition, you will own performance metrics, maintain traceability matrices, and ensure robust design documentation for audits. You will interact with suppliers and contract manufacturers to ensure component quality and supply continuity. The ability to thrive in a fast-paced, quality-driven environment and a hands-on approach to troubleshooting and optimization will be essential to your success.
Responsibility
- Lead and manage the development of new medical devices and product changes from concept through design verification, validation, and production readiness.
- Own design documentation and risk management activities, including FMEA, design controls, and traceability.
- Plan and execute comprehensive testing, reliability, and environmental qualification campaigns; interpret results and drive decision-making.
- Collaborate with R&D, QA, manufacturing, regulatory, and supply chain to ensure robust design transfer and process validation.
- Develop project plans, timelines, budgets, and resource requirements; track progress and report to stakeholders.
- Provide technical leadership and mentoring to junior engineers; lead design reviews and continuous improvement initiatives.
- Support manufacturing with process capability studies, equipment qualification, and troubleshooting to enable smooth scale-up and production handover.
Qualification
- Bachelor's degree in Mechanical, Electrical, Biomedical, or related Engineering field (Master's preferred).
- Minimum 5 years of product development experience, ideally in medical devices or high-risk industries.
- Strong knowledge of product development lifecycle, design controls, risk management (FMEA), DFM/DFX, and regulatory considerations (ISO 13485, 21 CFR Part 820 familiarity).
- Proven experience with design verification and validation methods, test method development, and data-driven decision making.
- Hands-on experience with manufacturing transfer, process validation, equipment qualification, and design transfer documentation.
- Proficiency with CAD tools, data analysis, and root-cause problem solving; excellent communication and cross-functional collaboration skills.
- Self-motivated, detail-oriented, and able to manage multiple priorities in a fast-paced environment.
- Fluency in English; proficiency in Malay or Mandarin is a plus depending on team composition.