Vacancy expired!
- Design, prototype, and test components and sub-assemblies to meet product objectives, including tooling, test stations and fixtures.
- Contribute to the design and development of new minimally invasive and orthopedic 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.
- Perform various quality assurance tasks such as review of quality records, including lot history records, and returned product records.
- Create and update quality system documents such as systems procedures in accordance with ISO 13485:2016 and FDA regulations.
- Maintenance of quality system records and files as required.
- Assist or perform investigations such as CAPA or Nonconformance investigations.
- Perform review of quality records to ensure GDP requirements are met.
- Performs visual and dimensional inspections and evaluations of components and devices according to product specifications.
- Complete First Article Inspections and supporting documentation.
- Maintain accurate and up to date records of all materials. These activities are conducted during incoming receiving, in-line inspections, returned materials, etc.
- Assist in the development and improvement of product assurance systems such as incoming and in-process quality control, statistical process control, nonconformity controls, product lot release testing, and finished goods control.
- 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.
- 2+ years of work experience in the medical device industry.
- Experience with ISO 13485, and FDA 21 cfr part 820.
- Proficient computer skills (MS Office, Excel).
Vacancy expired!