job description
Join a leading Japan-based multinational corporation (MNC) as a Production Development Engineer specializing in Medical Devices and Biomedical Science. This is a unique opportunity to work in the vibrant and scenic location of Bali, contributing to cutting-edge healthcare technology while enjoying a balanced 5-day work week. The role involves occasional travel, offering exposure to global best practices and innovative solutions in the medical device industry.
As a Production Development Engineer, you will play a pivotal role in the design, development, and optimization of medical devices, ensuring they meet stringent regulatory standards and deliver exceptional performance. You will collaborate with cross-functional teams, including R&D, manufacturing, and quality assurance, to bring life-saving products to market. This position is ideal for professionals passionate about healthcare innovation and eager to make a tangible impact in the biomedical field.
Trust Recruit is committed to fostering a dynamic and inclusive work environment. We offer competitive compensation, professional growth opportunities, and the chance to work in one of the world's most sought-after destinations—Bali. If you are a driven engineer with a background in medical devices or biomedical science, we invite you to apply and be part of our mission to advance global healthcare.
Responsibility
- Design and develop medical devices and biomedical products in compliance with international regulatory standards (e.g., FDA, ISO 13485).
- Collaborate with R&D and manufacturing teams to optimize production processes, ensuring efficiency, scalability, and cost-effectiveness.
- Conduct feasibility studies, risk assessments, and validation testing to ensure product safety, reliability, and performance.
- Lead or participate in cross-functional projects, from concept development to commercialization, ensuring timely delivery of high-quality products.
- Troubleshoot and resolve technical issues during the production phase, implementing corrective and preventive actions (CAPA).
- Stay abreast of industry trends, emerging technologies, and regulatory changes to drive continuous improvement in product development.
- Prepare and review technical documentation, including design specifications, test protocols, and regulatory submissions.
- Provide technical support and training to internal teams and external stakeholders as needed.
Qualifications
- Bachelor’s or Master’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
- Minimum of 3 years of experience in medical device development, production engineering, or biomedical product design.
- Strong knowledge of regulatory standards (e.g., FDA, CE, ISO 13485) and quality management systems (QMS).
- Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and product lifecycle management (PLM) tools.
- Experience with design control, risk management (ISO 14971), and validation processes.
- Excellent problem-solving skills and the ability to work in a fast-paced, multidisciplinary environment.
- Strong communication and interpersonal skills, with the ability to collaborate effectively with global teams.
- Willingness to travel occasionally for project requirements, training, or stakeholder meetings.