Biomedical Engineering Specialist

Biomedical Engineering Specialist (Bilingual Korean required)\n\nTimpl has partnered with a global medical device manufacturing company and is\nseeking for a Biomedical Engineering Specialist. \n\nJob Summary\n\nTechnical & Engineering Specialist is a key contributor to the successful launch\nand ongoing support of our diverse range of medical technologies, including\nsurgical robotic systems for neurosurgery and other related products. They play\na crucial role throughout the product lifecycle, from pre-launch activities such\nas establishing service infrastructure and developing protocols, to post-launch\nresponsibilities encompassing onsite and service center-based tasks. This\nincludes executing system delivery, providing technical assistance during\nsurgeries, conducting maintenance and troubleshooting both onsite and within the\nservice center, and ensuring adherence to regulatory standards and customer\nsatisfaction. Additionally, they actively contribute to continuous improvement\ninitiatives, train new personnel, and represent the company at exhibitions and\ndemonstrations.\n\nResponsibilities\n\nPre-launch Stage\n\n * Engage in establishing and building all aspects necessary for providing\n services in the United States during the pre-launch phase.\n * Provide support for the full establishment of the US service center, from\n initial setup to full operational capacity.\n * Assist in developing service processes and protocols specific to the US\n service center.\n * Undergo comprehensive training to prepare for all technical service\n activities, both onsite and within the service center.\n * Support the development of customer service plans and service manuals for the\n US and EU markets.\n * Assist in verifications and validations required for FDA and CE approvals.\n * Maintain regular communication and attend meetings with colleagues at the\n headquarters in South Korea, occasionally outside regular work hours\n\nPost-launch Stage\n\n * Coordinate and execute system delivery and installation processes.\n * Support surgeries alongside Clinical Specialists to ensure customers receive\n optimal technical assistance during the initial 1-2 years following the\n product launch.\n * Perform a wide range of onsite technical service activities, including\n preventive maintenance, field actions, system recalls, software updates, and\n upgrades.\n * Conduct advanced troubleshooting and repair of products received at the US\n service center.\n * Diagnose and repair all products in accordance with established procedures\n and within designated timeframes.\n * Fulfill administrative responsibilities such as managing parts inventory,\n documenting field activities, collecting customer feedback, and addressing\n complaints promptly.\n * Conduct regular inspections and maintenance of equipment and parts within the\n US service center.\n * Provide feedback to headquarters and actively engage in continuous\n improvement projects to enhance processes and efficiencies.\n * Maintain ongoing communication with customers, ensuring they are informed\n about the status of their requests and delivering superior customer service.\n * Train new Technical Specialist (TS) and Clinical Specialist (CS) personnel.\n * Support exhibitions and conduct system demonstrations as needed.\n * Demonstrate familiarity with operating room protocols and adhere to HIPAA\n standards.\n * Obtain and maintain required credentials from assigned hospitals by\n completing necessary training, vaccinations, and documentation.\n\nRequirements and Skills\n\n * Bachelor's degree in mechanical, biomedical, electrical, or computer\n engineering, or a related field, or equivalent.\n * Minimum of 4 years of relevant experience, or an advanced degree with 2 years\n of experience.\n * Prior experience in capital equipment development within the medical device\n field, or related technical service experience, is preferred.\n * Demonstrated ability to:\n * Apply technical knowledge to solve complex problems, including those not\n encountered previously.\n * Evaluate and prioritize multiple customer issues effectively.\n * Strong communication, organizational, and customer relationship management\n skills.\n * Experience in project management is highly desirable.\n * Comfort working in a multi-cultural environment\n * Proficiency in both English and Korean languages.