Staff R&D Engineer
Our client is Medical Device Start-up company (50 employees and growing) and they are looking for a Staff R&D Engineer.
- New product design, development, and optimization.
- Assist in the design and development process through ensuring products and processes meet the customer requirements throughout design and commercialization.
- 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.
- Participate in the creation of intellectual property.
- Clearly communicate ideas and findings to management and colleagues.
- Train and supervise staff on processes and technology.
- Establish and maintain a training and quality culture.
- Bachelor of Science Degree in Engineering, Manufacturing or Mechanical Engineering
- 5-8 years of experience in a regulated medical device environment
- A good working knowledge of the following areas:
- Mechanical design
- 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
- Catheter design a plus
Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.