Design Engineer
Responsibilities:
- Aspects of the product design and development of a project with a focus on innovative implantable medical devices that address the customer needs for a complete procedural solution.
- Plan, coordinate, and direct the application of Quality Engineering practices for New Product Development (NPD) and Design Transfer teams on a project basis from concept to commercialization.
- Working within a cross-functional project team through all phases of the product development process, planning and executing projects through the product launch.
- Work closely with members of the project core team (marketing, manufacturing, quality, etc.) to define user needs, generate design concepts and prototypes, perform design evaluations (such as tolerance analysis, FEA, DOE's, simulated use testing, etc.), and support development of product and process validation plans and testing.
- Manage the quality of technical team's implementation of incoming inspection, calibration, and inventory control systems. Plan, promote, and organize training activities related to quality system improvements.
- Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed
- Involved in test method development and testing of the proposed design.
- Work with manufacturing engineering and suppliers to optimize designs for manufacturability and produce prototypes.
- Develop an expert knowledge of our product lines and detailed knowledge of various anatomies and pathologies.
- Knowledge on mechanical engineering drawing principles.
- Experienced in Medical Device product development process
- Good Understanding of Design history file (DHF) / Technical Documentation
- Good Understanding of ISO13485 / US FDA 210CFR 820 requirements with respect to product realization/Design control.
- Good understanding of Risk Management principles per ISO14971.
- Experience with prototype design/fixture design and performing functional testing
- Experience with Design V&V, writing protocols, Testing, results analysis, application of statistical techniques, Report preparation
- Writing engineering justification memos
- Analyzing Design problems or deficiencies and developing solutions to resolve them.
- Experience in the ECR/ECO process and also proficient with PLM system (e.g., Agile/ windchill or any similar PLM tool)
- Must be proficient in SolidWorks
- Ability to work independently
- Good Communication
Requirements:
- A bachelor's degree is required; preferably in Mechanical, Biomedical, Industrial, or Chemical Engineering discipline
- An Advanced or master's degree is a plus
- Solid modeling experience
- Experience in product design, process development, device testing or prototyping- Capable of applying standard statistical practices and techniques in specific situations, and to adjust and correlate data and recognize discrepancies in results.
- Capable of working independently on assigned project activities in a cross functional team environment
- Must possess a good understanding of engineering fundamentals
- Good written and oral English communication skills