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.
