Job Description
Oneject is seeking a motivated Product Development & Technical Support Officer to join our innovative healthcare team. In this role, you will bridge the gap between product engineering and customer satisfaction, ensuring that our medical solutions meet the highest standards of quality and usability. You will collaborate with R&D, manufacturing, and clinical affairs to gather feedback, troubleshoot technical issues, and drive continuous improvement initiatives. If you are passionate about improving patient outcomes and have a strong technical aptitude, we invite you to contribute to meaningful advancements in the medical device industry.
As a PDTS Officer, you will be responsible for conducting postâmarket surveillance, analyzing field data, and providing timely technical assistance to healthcare professionals and endâusers. Your expertise will help shape product enhancements, support regulatory compliance, and enhance the overall user experience. Oneject offers a dynamic work environment where your ideas are valued, and your growth is supported through continuous learning opportunities and crossâfunctional projects.
Responsibilities
- Act as the primary technical liaison between customers, field service, and product development teams.
- Collect, analyze, and report product performance data from clinical and field settings.
- Provide timely technical support and troubleshooting for healthcare professionals using Oneject products.
- Assist in the creation and maintenance of product documentation, user manuals, and FAQs.
- Support design verification and validation activities by providing realâworld usage insights.
- Contribute to continuous improvement programs by identifying trends and recommending product enhancements.
- Ensure compliance with relevant healthcare regulations and quality management standards (e.g., ISO 13485, MDR).
- Participate in crossâfunctional meetings to voice customer needs and influence product roadmap decisions.
Qualifications
- Bachelorâs degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, or a related technical field.
- Minimum 2 years of experience in product development, technical support, or field application within the healthcare or medical device industry.
- Strong understanding of medical device regulations, quality systems, and risk management processes.
- Excellent problemâsolving skills with the ability to diagnose technical issues and propose effective solutions.
- Proficient in data analysis tools (e.g., Excel, Minitab) and technical drawing software (CAD) is a plus.
- Outstanding communication and interpersonal abilities to interact effectively with diverse stakeholders.
- Fluency in Bahasa Indonesia and English; additional languages are advantageous.
- Willingness to travel occasionally for site visits, training, and conferences.