Job Description
Join Intersurgical Medical Sdn Bhd as a Senior Development Engineer and lead groundbreaking innovations in medical device technology. This is an exciting opportunity for an experienced engineer to drive new product development from concept through to production, making a meaningful impact on healthcare solutions worldwide.
At Intersurgical Medical, we are committed to designing and developing cutting-edge medical products that improve patient outcomes. As a Senior Development Engineer, you will play a pivotal role in our engineering team, overseeing the entire product development lifecycle while ensuring compliance with stringent medical device regulations and quality standards.
You will collaborate closely with cross-functional teams including research and development, quality assurance, manufacturing, and regulatory affairs to deliver innovative solutions that meet market demands. Your expertise in engineering changes, testing, validation, and risk management will be instrumental in bringing safe and effective medical products to market.
This role offers competitive compensation, professional growth opportunities, and the chance to work with a dynamic team dedicated to advancing medical technology. If you are passionate about engineering excellence and want to contribute to life-saving innovations, we encourage you to apply.
Responsibilities
- Lead and manage new product development projects from concept initiation to successful production handover
- Oversee engineering changes, ensuring proper documentation and compliance with design control procedures
- Plan and execute testing and validation activities to verify product performance and safety
- Conduct comprehensive risk management analysis and implement mitigation strategies
- Coordinate and facilitate smooth project handover to production teams
- Collaborate with cross-functional teams including QA, regulatory affairs, and manufacturing
- Ensure adherence to medical device regulations and quality management systems
- Drive continuous improvement initiatives and support process optimization
Qualifications
- Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline)
- Minimum 5 years of progressive experience in product development or design engineering
- Proven track record in medical device or regulated industry experience is highly advantageous
- Strong knowledge of engineering principles, testing methodologies, and validation processes
- Experience with risk management frameworks (such as ISO 14971) and design controls
- Proficient in CAD software and engineering analysis tools
- Excellent project management, communication, and stakeholder management skills
- Detail-oriented with strong problem-solving abilities and analytical thinking