Description
Essential Duties and Responsibilities- Support all levels of requirements development including the development and implementation of performance, regulatory, manufacturing, labeling, and other requirements.
- Responsible for administration and management of requirements databases, risk databases, and traceability matrices using DOORs software.
- Support planning, execution, and reporting of ongoing risk management activities including DFMEA and PFMEA.
- Support configuration management of a large portfolio of medical products
- As part of larger projects, performs routine engineering assignments including product development process and change package quality documentation using good documentation practices (GDP).
- May write experimental, verification, and validation protocols and reports. May also develop and maintain records of testing and analysis performed.
- Assists in the preparation and participation in technical reviews and responsible for organizing data and preparing appropriate documentation for assigned projects.
- Other duties as assigned.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Experience with medical product requirements development and management. Significant experience with DOORs software is strongly preferred.
- Good written and verbal communication skills
- Ability to work as a collaborative team member.
- Strong attention to detail
- Ability to simplify and articulate complex and/or ambiguous requests into concise specifications.
- Ability to prioritize and manage multiple task assignments with minimal supervision
- Ability to solve routine design and engineering tasks including product design documentation with some assistance. Able to solve problems with periodic monitoring.
- Ability to discuss normally encountered technical or process issues, both verbally and in written form.
- Background and/or Experience:
- B.S.in Engineering and at least 2 years relevant experience. MS in engineering, medical product development, configuration management, and DOORs experience strongly preferred.
To find out more about Real please visit www.realstaffing.com