Senior R&D Engineer

As an R&D Engineer Supervisor/Assistant Manager in the R&D department, your role involves leading a team of engineers and technicians in designing, developing, and improving medical devices. You are responsible for ensuring that all R&D activities comply with regulatory requirements such as FDA and ISO 13485, quality standards, and company objectives. Your key responsibilities include: - Leadership & Supervision: - Supervising and mentoring a multidisciplinary team of R&D engineers and technicians. - Assigning tasks, setting priorities, and monitoring progress on multiple concurrent projects. - Fostering a collaborative, high-performance team environment focused on innovation and quality. - Product Development: - Overseeing the design and development of new medical devices and improvements to existing products. - Ensuring design control compliance, including risk management, verification/validation, and design transfer activities. - Collaborating with cross-functional teams throughout the product lifecycle. - Technical Expertise: - Providing hands-on technical support for prototyping, testing, and troubleshooting. - Reviewing and approving engineering documentation. - Supporting root cause analysis and implementation of design changes as needed. - Regulatory & Quality Compliance: - Ensuring R&D activities comply with FDA, ISO 13485, MDR, and other applicable standards. - Participating in design reviews, risk assessments, and audits. - Supporting preparation of technical documentation for regulatory submissions. - Project Management: - Planning and tracking R&D project schedules, budgets, and resource allocation. - Identifying risks and implementing mitigation strategies. - Reporting project status and performance metrics to senior management. - Continuous Improvement: - Driving innovation and process improvement within the R&D department. - Staying current with emerging technologies, materials, and regulatory trends in the medical device industry. Qualifications: - Education: - Bachelors or Masters degree in Biomedical Engineering, Mechanical Engineering, or related field. Advanced degree preferred. - Experience: - 3-5 years of R&D experience in the medical device industry, including at least 2 years in a supervisory or leadership role. - Proven experience in product design, development, and verification/validation under design control. - Familiarity with regulatory and quality requirements. Skills & Competencies: - Strong leadership and team management abilities. - Excellent project management, problem-solving, and analytical skills. - Proficiency with CAD tools and engineering documentation systems. - Effective communication and cross-functional collaboration skills. - Innovative mindset with a focus on patient safety and product quality. This is a full-time position with benefits including health insurance and provident fund. The work location is in person.,