Job Description
Job Description Summary
Performs a variety of engineering work in the design, development, and evaluation of medical devices. Contributes to the completion of specific programs and projects, usually under the direction of a project leader. Complete understanding and frequent application of a breadth of technical principles, theories and concepts in the field. Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough and practical. Works under general direction while independently determining and developing approaches to solutions. Frequent inter-organization and outside customer contacts.
Job Description
Contributes as a team member on development projects carrying out assigned responsibilities in a timely, diligent, safe, and professional manner. May act as a project leader.
Leads the design and development of new product and product engineering and applies engineering best practices and tools. Provides leadership in design analysis.
Leads product design verification and validation to satisfy product and customer requirement.
Conducts user/ergonomic studies with clinical professionals during the product development process in pursuit of user-based product design excellence.
Supports the development of products through knowledge of the clinical and physical performance requirements. This includes all aspects of the product design criteria, product function and customer needs.
Ensures quality in a product's design for usability, reliability, functionality, marketability, and manufacturability.
Applies Design to Cost and Design for Manufacturability methods to support project leader in achievement of project objectives.
Contributes-to-assembly-and maintenance the Design History File (DHF).
Provides technical support to Unit Business(es).
Supports the organization's intellectual property strategy by documenting data and independent, unique and patentable ideas that results from experimentations and concept generation activities.
Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System.
Travels as required by project scope and timing
Requirements
Master's or Bachelor's degree in mechanical engineering, biomedical engineering, or related engineering discipline
Experience in interventional device design and development.
PMP credential, DFSS certification, and/or Six Sigma Green/Black Belt.
Complete understanding of technical principles, theories and concepts in the field of product development. General knowledge of related disciplines.
Proficient in 3D CAD software (SolidWorks preferred).
Understanding of CAE tools (FEA, CFO, etc.).
Knowledge of statistical methods and analysis.
Demonstrated knowledge of applied mechanical engineering in product design and evaluation.
Strong aptitude for hands-on engineering testing and experimentation in a lab/shop environment.
Able to identify, break down and solve a variety of difficult technical problems.
Team player with excellent interpersonal and communication skills.
Proven ability to work independently with a minimum of supervisor input.
Disciplined and well-organized in documentation (plans, requirements, drawings, design reviews, and test methods).
Required Skills
Optional Skills
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Primary Work Location
SGP Tuas - Tuas
Additional Locations
Work Shift