Clinical Engineering Lead
6 days ago
About the Job
MVisioner (Hong Kong) Limited is a dynamic startup in Hong Kong that specializes in developing innovative medical devices.
We are currently seeking a Senior Clinical Product Engineer to join our team and contribute to the development of cutting-edge medical devices.
Job Description
- Engage with customers throughout the product development cycle to define clinical and workflow requirements for new products/feature development.
- Represent the Voice of Customer in the product development cycle and facilitate the translation into new projects through clinical review and evaluation.
- Work with field and medical personnel to define benchmarks for evaluating the clinical performance of these products/features.
- Fully understand the business unit's products and related clinical workflows and learn about competitive product offerings in different geographies.
- Advise on the interpretation of data from customers, provide insights and recommendations, and assist the team to identify future product opportunities.
- Own pre-defined tasks within a larger effort such as user needs, feature definition, and design validation, and drive them to on-time and high-quality completion.
- Drive, develop, and direct pre-clinical evaluation protocols, data analysis, and reports.
- Report significant progress and final findings of projects to management and product development staff in the company.
- Simulate or test aspects of new projects to evaluate prototypes and validate output as meeting customers' intended use requirements.
- Provide input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.
- Supervise and train junior engineers on completing assigned work.
Requirements
- Bachelor's Degree in biomedical, mechanical, electrical, or similar engineering field, or an equivalent combination of education and work experience.
- Minimum 6 years of progressively more responsible work experience in clinical medical device experience or equivalent, ideally with cardiac medical devices.
- Demonstrated ability to apply understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
- Strong analytical and problem-solving skills.
- Comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Meet deadlines in a timely manner.
- Travel approximately 10%, including internationally.
- Maintain regular and predictable attendance.
- Multitask, prioritize, and meet deadlines in a timely manner.
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