SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
- New product design, development and optimization.
- Assist in the design and development process
- Ownership of Risk Management activities including FMEAs, Hazards analyses, etc.
- Develop robust experimental designs and supervise their execution.
- Develop test methods and fixturing to support experimentation.
- Data analysis and reporting.
- Support for biocompatibility and sterilization process development.
- Troubleshooting of designs and processes for robust manufacturing.
- Partner with manufacturing engineering, quality and operations to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost effective.
- Liaise with external suppliers
- Support company goals and objectives, policies and procedures – Good Manufacturing Practices, ISO, FDA and other international regulations.
- Experience in a regulated environment, desired.
- A good working knowledge of the following areas:
Design of molded components
Statistical design and treatment of data
CAD (2D & 3D)
- An analytical approach to problem solving.
- Adept at managing multiple tasks, task prioritization and working in a team.
- Ability to analyze, understand and effectively communicate technical information
- Excellent written and verbal communication skills.
- A BS or MS in Mechanical or Biomedical Engineering or equivalent training/experience