The Product Development Technician role is a diverse and cross-functional role. They are responsible for the following essential duties:
Product Development and Building
- Design, prototype, and test catheters and sub-assemblies to meet product objectives, including tooling, test stations and fixtures.
- Contribute to the design and development of new catheters and minimally invasive products, under the direction of R&D engineers.
- Assist in writing procedures, specifications, and reports.
- Utilize established mathematical and scientific techniques to compile and analyze data with common analytical software such as Excel or Distribution Analyzer.
- Apply both technical intuition and analytical rigor and constructively provide critical technical assessment of their own and other’s work.
- Cross-train other team members when required.
- Perform duties in accordance with established procedures, including good documentation practices.
- Interact with internal teams to explore, troubleshoot and improve designs, fabrication processes and procedures.
- Create 3D models of products, components, and tools, as needed.
- Print prototypes and tools on 3D printer.
- Performs other duties as needed.
- Assembles product in a production environment in the cleanroom and in the lab, as directed by his/her manager.
- Perform preventive equipment maintenance tasks as directed by operations.
- Perform other routine operations functions as directed by operations.
- Perform weekly Product Processing Area cleaning as well as keeping daily lab tidiness and cleanliness.
- Assist in managing the inventory control system.
- Assist in performing receiving activities.
- Creates and performs calibration procedures for in-house calibration activities, as directed by engineering.
The ideal candidate will possess the following Experience, Knowledge and Skills:
- 2+ years of work experience in the medical device industry.
- Experience with ISO13485, and FDA 21 cfr part 820.
- Proficient computer skills (MS Office, Excel).
- Good verbal and written communication skills. Must be detail oriented and able to work in dependently.