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…