Deskripsi Pekerjaan
Are you a driven engineering professional looking to make a tangible impact in the healthcare sector? Join our team as a Senior R&D Project Engineer and lead the development of next-generation medical devices. In this pivotal role, you will oversee the entire product lifecycle—from initial concept and design to mass production—ensuring all deliverables meet rigorous industry standards and regulatory requirements. We offer a hybrid work model, allowing you to balance on-site collaboration with flexible remote work, fostering a healthy work-life balance while driving innovation.
As the technical lead, you will drive quality assurance protocols, conduct critical risk assessments, and coordinate with cross-functional teams to streamline production processes. This is an excellent opportunity for a seasoned engineer to advance their career in a supportive, growth-oriented environment.
Tanggung Jawab
- Lead end-to-end R&D project management for medical device development from concept to commercial launch.
- Ensure strict compliance with medical device regulations (e.g., ISO 13485, MDA, FDA) throughout the product lifecycle.
- Conduct risk assessments, design reviews, and failure mode analysis (FMEA) to mitigate product risks.
- Collaborate with cross-functional teams including design, manufacturing, quality assurance, and regulatory affairs.
- Define project milestones, track progress, and implement corrective actions to ensure timely delivery.
- Mentor junior engineers and provide technical guidance to the R&D team.
- Drive continuous improvement initiatives to enhance product performance and reduce production costs.
Kualifikasi
- Bachelor’s Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
- Minimum of 5-8 years of experience in R&D or Project Management specifically within the medical device industry.
- Strong working knowledge of medical device regulations, standards, and quality systems.
- Proficiency in CAD software (SolidWorks, AutoCAD) and project management tools.
- Excellent problem-solving skills and the ability to work in a fast-paced, quality-focused environment.
- Strong communication skills with the ability to present technical information to non-technical stakeholders.
- Valid Singapore work pass or citizenship.