A staff design engineer will use his/her project management skills and mechanical design experience to plan and execute various high-impact medical device design projects to enhance clients' commercialized product values.
Duties and Responsibilities
Lead cross-functional project teams at all stages of the product development process
Customized planning and execution of projects from concept to launch and initial production ramp-up
Support and/or lead product changes after launch based on business-defined needs
Work closely with other team members and suppliers to develop products with a focus on manufacturability and assemblability
Provide subject matter expertise across at least one area (e.g., plastics, metals, DFM/A)
Perform evaluation and qualification of components and assemblies, and lead the development of product and process validation programs and testing
Collaborate to produce prototypes and lead activities to optimize the design for manufacturability
Qualifications
Master's degree in Mechanical or Biomedical Engineering (or equivalent in a related field) with an emphasis on Mechanical; Advanced degree preferred
At least 5 years of relevant work experience; work experience in regulated industry engineering development is preferred
Expertise in mechanical processes and capabilities that impact design
Knowledge of design control, development, and manufacturing
Understand risk assessment activities and risk mitigation techniques, e.g., understand requirements and procedures for process risk assessment and validation