Design Quality Engineer Environment: Our client is a large medical device manufacturer that develops a number of Medical Device products. They are currently in need of an experienced Design Quality Engineer to support remediation activities surrounding risk management and design FMEAs as well as SFMEAs.
Responsibilities:
This role's emphasis is for supporting remediation of existing risk management and design control activities. Additionally, the role may include supporting risk management and design control related procedure updates. This person will be responsible for leading, conducting, and owning risk management activities including hazard analysis, system risk analysis, and various FMEAs as well as ensuring compliance to ISO 14971 and implementation of risk management best practices, that design controls are compliant with all relevant regulations, and that FDA and other regulatory knowledge and experience is applied to risk and testing assessments. Responsibilities will also include supporting design quality engineering activities in support of product development and life cycle processes including design controls, quality planning, risk management assessments, design reviews, test method development and validation, design verification and validation test plans and reports.
This individual should have experience contributing to the design, development, and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance as well as developing statistically sound sampling plans and perform data analysis. They should also be comfortable working with manufacturing engineering to ensure necessary process controls are in place for initial product launch and significant design changes and reviewing and approving change requests and Engineering Change Orders (ECO) as needed.
Required:- Medical Device
- Design Quality Engineering
- Design Controls / FMEA / SFMEA
- Risk management
- Remediation Experience
- IEC 62304 & IEC 60601
