Senior Clinical Engineer
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 theintended 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.