Suzhou, CHN
6 days ago
Senior Clinical Engineer
**In this role, you have the opportunity to make life better** Philips Healthcare Ultrasound in China is a leader in development and manufacture of high quality and high performance medical diagnostic ultrasound products to delight customers in China and worldwide. The company is looking for experienced clinical test engineer who can be a key member of a fast acting and solution oriented team on Philips Ultrasound projects for supporting our clinical testing activities to enable time-to-market launches. This position will work in fast-moving business environments where good skills of operating Philips Ultrasound systems and managing clinical tests are critical for success. Expansion of our Ultrasound business group in China means we have a challenging vacancy for a Clinical test Engineer who is prepared to take responsibility for contributing to our R&D project team to handle the clinical test and systems validation end to end from planning to finish on all required functional testing categories. The capability to work closely with Philips Ultrasound key functions that include RA, Research & Development, Manufacturing, and Marketing and with our global BG sites are critical for success. **You are responsible for** As a Clinical Test Engineer in Philips Healthcare Ultrasound R&D in China, you will report to the Philips Ultrasound R&D system and software manager in China; You will work on clinical test and system validation assignments of R&D projects, clinical related NMPA Type Testing activities of our medical diagnostic ultrasound systems and products. Working with both internal/external cross-functional teams of R&D, SC/MFG, Regulatory Assurance, Marketing, and also closely with Philips key technical interfaces and RA team to execute the clinical test and system validation activities are required. Your main responsibilities are: + Understanding user needs and intended use specifications and operations of features and applications to the satisfaction of the purpose of the intended use. + Working as a key contributor in our clinical test and system validation. This includes but not limit to contributing to local for local projects, cost innovation projects, local innovation projects. + Exercising skills in solving clinical testing problem; Working closely with BG Ultrasound R&D and V&V teams to handle testing issues and deliver results with consistency and meet the regulatory and QMS requirement. + Capable of operating, maintaining, and calibrating the clinical test equipment and devices to satisfy regulatory and QMS requirement. + Engaged in and contribute to the product technical requirement (PTR) drafting for NMPA type testing, working and partnering with the RD team members, Regulatory and Marketing colleagues. + Capable of communicating and working with Philips Ultrasound RA, Clinical Event team members to understand and fulfill the NMPA requirement from clinical and validation perspective. + Working closely with China RA team to support them to respond NMPA reviewers during deficiency response phase of NMPA registration. + Working with project management and team leadership and members for sound judgment and making decisions. + As the clinical experts, share the clinical knowledge, provide clinical insight and coach the R&D team from clinical use perspective. + Responsible for the assigned tasks’ quality of work, reliability, schedule (if appropriate), cost and delegation of tasks.
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