job description
Join Biosensors International Group as a Senior R&D Engineer and lead the innovation of cutting-edge medical device technologies. Based in the vibrant hub of Canggu, Bali, you'll collaborate with a global team to develop life-changing healthcare solutions. This role offers a unique opportunity to merge engineering expertise with medical advancements in a dynamic, tropical work environment.
As a Senior R&D Engineer, you will drive the entire product development lifecycle—from conceptualization to commercialization—while ensuring compliance with international medical standards. Your work will directly impact patient outcomes worldwide, making this a rewarding career for passionate engineers.
Biosensors International Group is a pioneer in medical technology, known for its innovative cardiovascular and diagnostic solutions. We foster a culture of creativity, precision, and continuous learning, supported by state-of-the-art R&D facilities in Bali.
Responsibility
- Lead the design, development, and testing of next-generation medical devices, focusing on cardiovascular and diagnostic technologies.
- Collaborate with cross-functional teams (clinical, regulatory, manufacturing) to ensure seamless product transitions from R&D to production.
- Conduct feasibility studies, risk assessments, and validation testing in compliance with ISO 13485, FDA, and CE regulations.
- Optimize existing products through iterative design improvements and cost-effective engineering solutions.
- Mentor junior engineers and provide technical guidance to foster a culture of innovation.
- Stay abreast of emerging medical technologies and integrate relevant advancements into product roadmaps.
- Prepare and review technical documentation, including patents, design history files, and regulatory submissions.
- Liaise with global stakeholders to align R&D initiatives with market needs and business objectives.
Qualifications
- Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, or a related field. PhD preferred.
- Minimum 7 years of experience in medical device R&D, with a proven track record of successful product launches.
- Proficiency in CAD software (SolidWorks, AutoCAD) and FEA/CFD simulation tools.
- Strong knowledge of medical device regulations (ISO 13485, FDA 21 CFR Part 820, EU MDR).
- Experience with prototyping, 3D printing, and rapid manufacturing techniques.
- Excellent problem-solving skills and ability to troubleshoot complex technical challenges.
- Demonstrated leadership in managing R&D projects and cross-functional teams.
- Fluency in English; additional languages (e.g., Indonesian, Mandarin) are a plus.