Principal Engineer (Vascular Therapy)
Report to:
Director
Location:
Shanghai, R&D Centre
Summary:
Responsible for product development project from concept generation to commercialization. Works under the general direction of project objectives for project development including CAD/CAM, computational analysis, prototyping and manufacturing etc.
ESSENTIAL FUNCTIONS:
? Development of mechanical devices.
? Is responsible for overall system design and interface design among different portions
? Collaborates with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
? Coordinates and manages state of art technology research, patent disclosures and participate in patent portfolio decisions.
? Works on complex technical projects and provides highly innovative solutions that require the regular use of ingenuity and creativity.
? Independently determine and develop proactive approaches to solutions which are imaginative, thorough, practical, and consistent with organization objectives.
? Contributes inventions, new designs and techniques regarded as advances in the medical and technical/scientific community.
? Writes engineering reports and creates presentations as required to document and communicate results.
? Uses advanced techniques to anticipate, identify and provide technical solutions to a wide range of difficult problems.
? Participates in FMEAs and follows up on generated recommendations.
? Creates and evaluates prototypes to generate concept and model approvals.
? Prepares reports, presentations and spreadsheets of an analytical and interpretative nature.
? Tests and optimizes the design by conducting experiments and evaluations including numerical verification (FEA analysis, tolerance analysis etc.)
? Interacts with suppliers, participates in DFM and DFA processes to access component and assembly manufacturability.
? Participates in pre-clinical in vivo labs, observing cases in hospitals and through planned and unplanned customer interactions.
? Participates in, setting up, debugging and initial running of the assembly line.
? Coach, motivate, and foster development of junior technical staff.
? Adheres to safety policy procedures.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
? Other duties as assigned with or without accommodation.
? Continue to develop skills through additional training and educational programs
MINIMUM REQUIREMENTS:
Education Required:
Education in Mechanical Engineering and/or biomedical engineering with concentration in Biomechanical required. PhD with a minimum of 5 years relevant experience; or MS with a minimum of 8 years relevant experience; or BS with a minimum of 10 years relevant experience required. A minimum of 3 years Med Device experience preferred.
Skills/Qualifications:
? Technically savvy; must be able to discuss, understand and make decisions regarding a wide array of engineering disciplines and complex technical issues
? Thorough understanding of medical device industry and competitor products. Working knowledge of other related disciplines.
? Thorough understanding of clinical and regulatory pathways, IP and internal processes.
? Takes initiative in keeping current with technology developments in specialized area.
? In depth knowledge and wide application of technical principles, theories, and concepts in related field of expertise to develop innovative approaches to work.
? In-depth clinical knowledge for uses of product.
? In-depth knowledge of anatomy relative to surgical procedures for specific products.
? Effectively communicates and works cooperatively with others as part of a team.
? Knowledge of and ability to design reliable and innovative mechanical systems and mechanisms for consumer products.
? Knowledge of manufacturing processes including stamping, molding, machining, MIM and extrusions.
? Knowledge of statistical process control in mass production as well as Six Sigma (DFSS) for design validation and optimization.
? Knowledge of and wide application of drafting practices, GD&T, 1D tolerance analysis and 3D analysis.
? Knowledge of kinematic and stress analysis of mechanical systems.
? Familiar with related fields of engineering such as electrical, pneumatics, optics, and software.
? Knowledge of clinical settings such as in vivo labs, and hospital operating rooms.
? Knowledge of anatomy and surgical procedures and instrumentation.
? Knowledge of different material, both plastic and metallic material preferred.
? Preferred: Successfully led a medical device project to market.
? Good oral and written communication skills.
? Fluency in English and Mandarin required.
Skills/Competencies:
? Functional/Technical Skills
? Action Oriented
? Self Development
? Time Management
? Listening & Communication Effectiveness
? Problem Solving
? Customer Focus
? Planning
? Decision Quality
? Organizing
? Creativity
Other Skills:
? Working knowledge of Microsoft Office
? Hands on experience with 3D CAD software (ProE preferred).
? Working knowledge of FEA software, CE-Tol, Minitab, MathCad, LabView.
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
? Regular cross functional contact at all levels. May participate in a cross GBU Team. Frequent contact with customers and external service organizations.
WORKING CONDITIONS:
? Work usually performed in an office setting and or laboratory.
? Occasional exposure to Clean Room environment and shop elements such as machines, noise, dust, odors, oils, greases, grinding debris, compressed air, metal shavings, fumes.
? Travel as required.
Please send your CV to [email protected] or dial +86-18217360433 for more inquiry. |
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