In this role, you have the opportunity to
Coordinate with PMO, PE and cross-functional team to execute Value Engineering and Quality/Availability/Cost improvements. In-scope products will include patient monitors, medical consumables and accessories, and potentially any products in MA.
You are responsible for
Being responsible for the product definition and mechatronic solutions (including the mechanical and documentation aspects) in the development, realization and lifecycle management of medical devices and components.
Working with cross-function team to support device and component development via defining and realizing models and test set-ups.
Leading or develop new and optimize existing product concepts within cross-functional teams, or leading and controlling outsourcing of these activities, and aligned with R&D development project roadmap.
Leading or carrying out the detail design of key components, and supporting their realization.
Participating and leading as key competence resource in cross-functional and cross-business teams.
Being responsible for the manufacturability, interfacing and introduction of new technology and methods in manufacturing sites.
Working closely with the system engineers, architects, other functional representative and the project managers
Working closely with the commercial department to truly understand the customer’s technologic challenges in order to offer projects, tailored services & technical support.
Design process compliance assurance, design quality assurance and design reviews
Building an effective network with customers and suppliers, actively looking around to acquire new insights, to strengthen the knowledge base and competence of yourself in the domains of medical device and components.
Managing the product design documentation (the BOM and the Design History File).
Conducting the root-cause analysis of design, production problems and consumer complaints.
You are a part of
A professional R&D team with around 70 team peers in Shenzhen China.
To succeed in this role, you should have the following skills and experience
Bachelor's degree in Mechanical Engineering minimum (Master’s degree preferred).
8 years industrial experience (experience in medical device industry preferred).
Track record of product development life cycle from requirement, to design, to prototype, to verification and validation, to transfer to manufacturing, and to product release in medical device industry.
Strong knowledge and working experience in one or more relevant fields of competency, such as mechanical structure, plastic, heating & cooling, fluid mechanics, materials engineering, or in mechatronics and bio-mechanics.
Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international. This includes but is not limited to organizations such as FDA, IEC, ISO, CFDA, ACR, AAPM, COCIR, MITA and other directives such as RoHS and WEEE. Examples include: FDA 21CFR820.30, IEC 60601-1 and ISO 14971.
Design control process compliance management track record.Skills:
Demonstrable clear oral communication, as well as well-organized documentation skills; excellent command of written and spoken English
Ability to drive solutions and decisions in a cross-functional team environment
Experience in requirements management tool, design quality management tools, risk management tools, and problem reporting/defect tracking tools.
Hands on experience on FMEA, Fault Tree analysis, mechanical design tools – CADs.
Demonstrated capability to conduct and lead technical reviews of product design elements
Demonstrated ability in leading evolution of a complex feature, where analysis requires both evaluation of multiple candidate solutions and significant evaluation of intangibles.