As a DFMEA and Compliance Engineer, this individual will serve as a key member of the development engineering department focused on new product development. The position will be responsible performing DFMEA on new designs as well as ensuring products are designed to meet all regulatory and compliance requirements
- Review proposed designs to ensure they will comply with Medical device standards. Work closely with system architect and other team members during new product development process
- DFMEA analysis completed and controls implemented to ensure products are designed with a focus on safety and reliability
- Knowledgeable in applying WCCA, MTBF, HASS and HALT and other reliability assessment methods to electronic components and assemblies.
- Interface with Regulatory Department to ensure products are designed to meet country specific safety standards
- Shepard new products through IEC60601 approval process including 2nd, 3rd and 4th editions as necessary. Provide hands on supportworking with off-site test agencies to obtain regulatory approval.
- Familiar with testing products for EMC compliance and single fault conditions
- Proficient in Microsoft Office, Excel, and Word
- Hazard and Risk Analysis documentation
- Other Regulatory/Compliance documentation or activities as needed
- Ensure that all products/processes to be developed comply with FDA, and other regulatory standards/guidelines as well as company SOPs.
- 8+ years of directly related experience in a regulated industry.
- Bachelor of Science Electrical Engineering preferred
- Intimate familiarity with IEC 60601 Compliance for Medical Devices
- Experience performing DFMEA on complex medical devices
- Experience with laser devices a plus