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