Deskripsi Pekerjaan
Are you a seasoned engineer with a passion for life-saving technology? Intersurgical Medical Sdn Bhd is currently seeking a highly motivated Senior Development Engineer to join our elite product development team in Bukit Minyak, Penang. As a key player in our engineering division, you will be responsible for driving the lifecycle of high-precision medical devices from initial conceptualization to full-scale production handover.
This role offers an exceptional opportunity to work in a fast-paced environment where your technical expertise in risk management, design validation, and engineering change control directly impacts global healthcare outcomes. We are looking for a proactive problem-solver who excels in cross-functional collaboration and is dedicated to maintaining the highest standards of quality and regulatory compliance.
At Intersurgical, we foster an environment of continuous improvement and technical excellence. If you are ready to lead new product development initiatives and influence the future of medical engineering, we invite you to join our growing team.
Tanggung Jawab
- Lead end-to-end new product development (NPD) projects, ensuring alignment with design requirements and regulatory standards.
- Oversee engineering change requests (ECR) and engineering change orders (ECO) to ensure process integrity.
- Execute comprehensive product testing and design validation protocols to ensure device efficacy and safety.
- Manage technical risk assessments, including DFMEA and PFMEA, throughout the development lifecycle.
- Collaborate with cross-functional teams to ensure seamless project handover from R&D to mass production.
- Develop and maintain technical documentation, including CAD drawings, BOMs, and design history files.
- Identify opportunities for design optimization to improve manufacturing efficiency and product reliability.
- Provide technical leadership and mentorship to junior engineers and technicians.
Kualifikasi
- Bachelor’s Degree in Mechanical, Biomedical, or Manufacturing Engineering (or a related field).
- Minimum 5+ years of experience in product development, preferably within the medical device or high-precision manufacturing industry.
- In-depth knowledge of ISO 13485 and relevant medical device regulatory requirements.
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and product lifecycle management (PLM) tools.
- Strong background in design validation, verification, and statistical analysis (DoE, Six Sigma).
- Proven ability to manage complex projects, meeting tight deadlines without compromising quality.
- Excellent communication skills with the ability to lead cross-departmental technical discussions.
- Strong analytical mindset with a passion for continuous improvement and innovation.