Design Assurance Engineer Job at RTI Surgical Inc
This position is responsible for support of new product development, process optimizations, regulatory submissions and quality improvement initiatives. Applies scientifically based competencies to commercialize products or technologies for medical applications. They will be a self-starter, have a hands-on approach in performing their work duties, and be able to work independently. This position will help RTI Surgical maximize the amount of patients served while maintaining a high level of quality and safety.
Responsibilities:
- Will serve as a core team member of a cross functional project team whose responsibilities may be to conduct studies directed toward the development of novel products or processes
- Performs standard scientific assignments that are a significant portion of a larger project
- Participates and consults with the internal and external scientific community to maintain a state-of-the-art knowledge for application to achieving successful experimental outcomes
- Evaluates experimental results for validity and conformance to acceptable scientific method
- Keeps abreast of current technologies and regulations in area of specialty including that of the tissue processing and engineering field
- Coordinate or perform validations to support regulatory submissions or product launches
- Provides ownership of design control deliverables required to support both new product development projects and design change projects.
- Document risk management to ensure design and process controls adequately mitigate risk
- Applies experimental and theoretical techniques to achieve project specific objectives
- Reviews and edits internal documentation for team members and assists in the preparation and presentation of materials for internal or external technical reviews
- Compiles design history files
- Collaborate cross-functionally with design, engineering, process, and/or production teams to meet quality, productivity, and cost objectives
- Other duties as assigned
Education/Experience Required:
- Bachelor of Science Degree, (or equivalent experience) with discipline in Life Science (e.g. microbiology, molecular biology, biotechnology).
- 0-3 years Life Science/Medial experience
- Experience using Microsoft Office
- Basic understanding of project management is preferred but not required
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