What are the responsibilities and job description for the Design Quality Engineer position at I3 INFOTEK INC?
Role: Design Quality Engineer - NPD
Location : Newton, MA
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 on ongoing New Product Development activities for surgical robotics products.
Responsibilities:
This role’s emphasis is for supporting new product development activities for a surgical robotics system, including consumables that are plastic injection molded. Additionally, the role may include supporting risk management and design control related procedure updates and development. 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.
This is NOT a remediation role. It is purely product development.
Required:
- Medical Device (specifically Electromechanical Products)
- Design Quality Engineering
- Design Controls / FMEA
- Risk management
- New Product Development project experience 5-7 years
- Project experience with Either extensive Capital Equipment HW/SW Experience OR Consumables experience
