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Philips Senior System Engineer- Ultrasound R&D China, Jiangsu 192341999
Your responsibilities
As a system engineer in Philips Healthcare Ultrasound R&D in China, you will report to the Philips Ultrasound R&D director in China; You will work on leading the PTR specification challenges in our NMPA Type Testing projects for NMPA certification of our medical diagnostic ultrasound systems and products. Working with both internal/external cross-functional teams of R&D, Regulatory Assurance, Marketing, ISC, also closely with Philips BU key technical interfaces and RA team to execute type testing activities are required. You will also be working with Philips Ultrasound R&D colleagues to support the China local product releases and productions.
Your main responsibilities are:
- Responsible for leading an Ultrasound China local product’s NMPA type testing project with solid project planning, risk management, issues resolution, and final closure. Leading the project’s daily activities with project team tasks coordination, resource allocation, budgeting, and end to end execution to success that includes PTR-config confirmation-pre-testing-Type Test-Deficiency Response-GMP.
- Working with BG R&D SME, RA, Marketing to deliver PTR with technical contents for the China local product certification in China, exercising and applying strong knowledge of IEC and NMPS standards.
- Provide overall technical leadership and responsible for realization of our China local products’ full systems product release/life cycle management to ensure quality and NMPA compliance.
- Understand system architecture, system decomposition, allocation of derived requirements down to HW/SW element and part level and related traceability,
- Apply theory of operation of features targeted for NMPA registration for providing technical support on NMPA questions in NMPA type testing, during the NMPA submission and reviews, and GMP audit.
- Trade-off of product/system design specifications and interfaces, determine feasibility of potential solutions, and leading technical & design reviews
- Work as a key R&D member on the NMPA testing project team with members from all impacted functions that include R&D, RA, PI, MFG, to deliver project success with completion of the type testing, deficiency response actions, and GMP audit on time and on target.
- Work closely with project managers and project leaders at BU to ensure quality deliverables and compliance
- Understanding and excising knowledge of NMPA, GB, IEC and related standards in managing project activities for compliance
- Exercising sound judgment within broadly defined system engineering and type testing practices and policies in selecting methods, techniques, prioritization, tradeoffs, and evaluation criteria for obtaining results.
You will be working in the Philips Healthcare Ultrasound Research and Development organization in SuZhou/Shanghai, China, also the Business Units of Ultrasound in North America. You will also work with manufacturing/SC team in Suzhou.
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
- Competitive compensation and benefits package.
- Annual leave.
- Extensive set of tools to drive your career, such as a personal development
budget, free training and coaching - Healthy work-life balance
- Continuous career development in Philips.
We are looking for a highly professional system engineer with
- Requires an MS degree in Bio Engineering, EE, ME, Materials, Industrial Engineering, Physics, and/or Science.
- >3-5+ years of work experience in medical device industry as system engineer; Experience and/or strong knowledge in Ultrasound Engineering is preferred. Strong knowledge and experience working with NMPA regulation testing is a strong plus.
- Demonstrated strong leadership and team skills, with solid track record in system engineering & deliver result. Capability of using the latest technologies and resources, often realizing systems based on unverified specifications, making a substantial contribution to the innovation of product and processes.
- Ability to work effectively in managing technological complexity of products in multi-disciplinary setting; Strong ability to operate independently; ability to work collaboratively and resolve conflict across different departments.
- Skills in contributing in developing partly and sometimes wholly new product, process or technology, capability for eliciting, reviewing, and characterizing stakeholder feedback; creating and reviewing system-user interaction model with various Systems Engineering related Methods/tools.
- Quality-conscious, result-oriented, and ready to take ownership
- Acts as a mentor to junior engineering team members, and steer skills to focus on high priority and project problem solving skills;
- Demonstrated history of solid occupational ethics, good track record of working well in engineering team environment.
- Good verbal and written communication skills. Able to effectively communicate and/or present complex technical issues to engineers and managers
- Having adequate product-level knowledge of ultrasound systems and some knowledge in a variety of specialties; some clinical knowledge is a plus. Knowledge and understanding of technical requirements associated with area of work and capable of learning how it relates to the final product.
- Proficient in both Chinese & English
Our hybrid working model is defined in 3 ways:
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