Position Summary: The Senior Mechanical Design Engineer will be responsible for the successful design and development of disposable medical device products. This position is responsible for all aspects of the product development cycle from product conception through development and manufacturing transfer within a startup environment. The applicant must have a strong working knowledge of mechanical design and testing practices for high volume injection molded plastic parts and assemblies. This position will also have project management responsibilities for multiple products in different phases of development. Strong communication and leadership skills are required.
- Responsible for the development of medical device products from concept through development, testing and manufacturing scale-up.
- Design of complex high volume injection molded plastic parts and assemblies using Solidworks, FEA, strong electro-mechanical fundamentals.
- Strong understanding and experience with material selection in applications that must meet challenging requirements such as high stress, fatigue, creep and sterilization compatibility.
- Project Management responsibilities will include vendor and supplier management, directing design and test technician resources, developing and maintaining project schedules and budgets.
- Apply new technologies and processes to optimize product design and development methods and processes.
- Create specifications, define testing protocols, monitor or execute testing, issue qualification test reports and comply with QSR requirements.
- Perform engineering analysis such as tolerance studies and FEA.
- Fabricate concept prototypes and working prototypes with the use of in house manufacturing and rapid prototype sources
- Interface with Quality Assurance, Operations, Marketing, Vendors, Customers and Physicians.
- BS degree in Mechanical Engineering or higher
- Minimum of 10 yrs experience in the R&D/product development with 5+ years of medical device experience
- Experience with disposable medical device technologies, design, verification testing, design/process validation and manufacturing
- Experience in medical device design control procedures
- Experience with functioning in a highly regulated environment with exposure to ISO13485 and FDA environment
- High innovative ability and motivation to work on own initiative
- Excellent communication, planning, and organizational skills
- Strong knowledge of Polymer materials specifically medical grade plastics and elastomers
- Minimum 5 years using Solidworks to develop detailed parts, drawings, and assemblies.
- Ability to apply statistical methods using software such as Minitab a plus