Staff Engineer Quality Assurance - CT NPD

Purpose of Position:

This position is responsible for leading and completing Quality Engineering activities as part of a New Product Development (NPD) team creating disposable products and electro-mechanical accessories for the CT market.  The individual will work closely with other members of the NPD team and partner(s) on design control activities, pre-production Quality Assurance, manufacturing process validation, supplier quality, and Quality Agreement management.

The position will be instrumental in leading and managing Quality Engineering activities to completion, interfacing with internal Regulatory resources for submissions and device approvals, assisting with supplier integration, developing internal and external relationships, initiating new quality assurance and business processes, and ensuring overall project success.

The position will support development activities to assure a robust design with effective control procedures implemented for product and process design, design verification, process validation, manufacturing start up, and product launch.  The individual will possess and be able to leverage a high level of quality engineering and project management expertise.  Individual must be willing to periodically travel internationally.

Job Requirements:
Technical and Behavioral Requirements:

1. Bachelor`s Degree in Engineering (Mechanical preferred) and minimum seven years overall engineering experience.
2. Demonstrated knowledge of Quality System Requirements (FDA, ISO) and Medical Device Directive (MDD) as applied to New Product Development and project management.
3. Five or more years experience in Medical Device manufacturing, manufacturing process validation, and quality system design control activities related to disposables or catheters.
4. Previous experience with integrating suppliers in an external design and development project (ideally with an overseas supplier).
5. Exposure to medical device packaging requirements for sterile products
6. Experience and knowledge of sterilization validation requirements and activities
7. Ability to prepare, review and approve design verification and validation test plans.
8. Previous experience is required with statistical sampling principles and quality tools (e.g., DOE, process flow charting, FMEA, hazard analysis, etc.)
9. Six Sigma Black belt and CQE are preferred.
10. Knowledge of syringe and disposable design is highly desirable.
11. Must demonstrate global perspective and be able to work in a cross-cultural environment.
12. Demonstrated high performance orientation, detail orientation, and market knowledge.
13. Excellent written, persuasion and consensus building, listening, and verbal communication skills.
14. Demonstrated planning and organizing, customer focus, and cross-functional collaboration/teamwork skills; change implementation, and problem solving skills.
15. Working knowledge of Microsoft Office applications and statistical software.