Biomedical Engineering Specialist (Bilingual Korean required)

Timpl has partnered with a global medical device manufacturing company and is seeking for a Biomedical Engineering Specialist.

Job Summary

Technical & Engineering Specialist is a key contributor to the successful launch and ongoing support of our diverse range of medical technologies, including surgical robotic systems for neurosurgery and other related products. They play a crucial role throughout the product lifecycle, from pre-launch activities such as establishing service infrastructure and developing protocols, to post-launch responsibilities encompassing onsite and service center-based tasks. This includes executing system delivery, providing technical assistance during surgeries, conducting maintenance and troubleshooting both onsite and within the service center, and ensuring adherence to regulatory standards and customer satisfaction. Additionally, they actively contribute to continuous improvement initiatives, train new personnel, and represent the company at exhibitions and demonstrations.

Responsibilities

Pre-launch Stage

Engage in establishing and building all aspects necessary for providing services in the United States during the pre-launch phase.
Provide support for the full establishment of the US service center, from initial setup to full operational capacity.
Assist in developing service processes and protocols specific to the US service center.
Undergo comprehensive training to prepare for all technical service activities, both onsite and within the service center.
Support the development of customer service plans and service manuals for the US and EU markets.
Assist in verifications and validations required for FDA and CE approvals.
Maintain regular communication and attend meetings with colleagues at the headquarters in South Korea, occasionally outside regular work hours

Post-launch Stage

Coordinate and execute system delivery and installation processes.
Support surgeries alongside Clinical Specialists to ensure customers receive optimal technical assistance during the initial 1-2 years following the product launch.
Perform a wide range of onsite technical service activities, including preventive maintenance, field actions, system recalls, software updates, and upgrades.
Conduct advanced troubleshooting and repair of products received at the US service center.
Diagnose and repair all products in accordance with established procedures and within designated timeframes.
Fulfill administrative responsibilities such as managing parts inventory, documenting field activities, collecting customer feedback, and addressing complaints promptly.
Conduct regular inspections and maintenance of equipment and parts within the US service center.
Provide feedback to headquarters and actively engage in continuous improvement projects to enhance processes and efficiencies.
Maintain ongoing communication with customers, ensuring they are informed about the status of their requests and delivering superior customer service.
Train new Technical Specialist (TS) and Clinical Specialist (CS) personnel.
Support exhibitions and conduct system demonstrations as needed.
Demonstrate familiarity with operating room protocols and adhere to HIPAA standards.
Obtain and maintain required credentials from assigned hospitals by completing necessary training, vaccinations, and documentation.

Requirements and Skills

Bachelor’s degree in mechanical, biomedical, electrical, or computer engineering, or a related field, or equivalent.
Minimum of 4 years of relevant experience, or an advanced degree with 2 years of experience.
Prior experience in capital equipment development within the medical device field, or related technical service experience, is preferred.
Demonstrated ability to:
- Apply technical knowledge to solve complex problems, including those not encountered previously.
- Evaluate and prioritize multiple customer issues effectively.
Strong communication, organizational, and customer relationship management skills.
Experience in project management is highly desirable.
Comfort working in a multi-cultural environment
Proficiency in both English and Korean languages.

Job Information