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A leading medical device manufacturer in Indonesia is seeking an experienced engineer to oversee all engineering activities on projects. The role involves ensuring compliance with quality and regulatory standards, leading team coordination, and managing project budgets. Ideal candidates have extensive experience in the medical device industry and strong project management skills. Join our innovative team to contribute to high-quality product development and entry into new markets.
Oversee all engineering activities in assigned projects to ensure full compliance with quality requirements and regulatory standards.
Review and verify that all project phases follow established engineering procedures and industry best practices.
Ensure timely resolution of engineering-related issues to support smooth project execution.
Lead regular team meetings to review project progress, challenges, and action plans.
Facilitate effective communication among team members to ensure alignment on project goals.
Monitor task execution and provide direction for improvement when needed.
Evaluate and approve technical designs, drawings, and specifications for medical device projects.
Ensure all technical documentation meets regulatory and quality standards relevant to medical devices.
Provide expert judgment and recommendations for engineering improvements.
Work closely with R&D, Quality Assurance, Production, and other departments to support efficient product development.
Coordinate cross-functional activities to ensure smooth project workflows and timely decision-making.
Facilitate problem-solving between internal stakeholders to optimize project outcomes.
Manage project budgets, schedules, and resources to ensure optimal performance and timely delivery.
Track project milestones and adjust plans when necessary to maintain alignment with objectives.
Ensure team workloads are balanced and resources are utilized effectively.
Develop and implement training plans to enhance the technical competencies of engineering team members.
Identify skill gaps and provide targeted coaching or development initiatives.
Promote continuous learning and skill advancement within the engineering team.
Prepare and submit regular reports to management on project status, engineering performance, and team initiatives.
Highlight key achievements, risks, and required support to ensure transparency and informed decision-making.
Maintain clear communication channels with senior leadership and relevant departments.
Maintain and actively participate in Health, Safety, and Environment (HSE) programs.
Identify, anticipate, and mitigate potential hazards in the workplace.
Ensure engineering activities comply with internal HSE policies and relevant regulations.
PT. Oneject Indonesia is a Medical Devices manufacturer produces Auto Disable Syringes.
As a pioneer of AD syringes manufacturer in Indonesia in providing safe injections, PT. Oneject Indonesia has contributed to reduce the number of standard syringes, which are produced and distributed in Indonesia. Our product is the market leader of AD syringes in Indonesia with 90% market share.
PT. Oneject Indonesia is growing continuously, not only in Indonesia. We have been exported our AD syringes to Asian countries and ready to enter the European market. We ensure the quality of the products at each stage of the production process starting with the selection of medical grade raw materials, the complete manufacturing process to the point of finished product. The products are monitored and controlled by our QC Department as per requirement of ISO 9001:2015 and ISO 13485:2016, in cooperation with our R&D Department, in order to continuously monitor the improvement, innovation and thereby increase our product quality.