The Senior/Staff Quality Engineer supports new product development and sustaining manufacturing through the application of Quality Engineering skills. This person will handle multiple projects and tasks, from product inception through product launch and manufacturing. Additionally, they will play an active role in the processes to ensure products meet quality standards consistent with Hansen Medical policies, while meeting all design control and other regulatory requirements. The Senior/Staff Quality Engineer will represent Quality and Interface with Engineering, Regulatory and Manufacturing departments regarding design control, risk management and usability activities for clinical and commercial product on project teams for both Design and Manufacturing.
- Provides proactive strategic direction, planning and support related to Quality Assurance for New Product Development Teams
- Develop and maintain Quality Plans throughout the product life cycle beginning with project inception/initiation
- Contribute as a New Product Development Core Team Member in Risk Management activities including Design/User/Process FMEAs and other risk analysis activities.
- Oversee the development and implementation of standards, methods and procedures for development, testing and evaluating product performance and reliability.
- Review Design History Files for compliance to standards; work with NPD Teams to resolve all technical and documentation issues.
- Maintain and comply with Hansen Medical SOP’s. Review procedures to ensure adequacy for device development to conform to business and Quality Management System requirements
- Coordinate review and resolution of customer complaints
- Participate in review of field issues and software defects encountered during development processes and clinical trials
- Enforce corrective actions necessary to assure conformity to quality specifications
- Participate in internal audits as needed
- B.S. degree in Engineering or equivalent combination of education and experience; M.S. preferred
- CQA/CQE certification a plus
- 10-15 years experience, with 5+ years in the Medical Device industry
- 5+ years experience in a capital equipment/software product environment
- Management experience a plus
- Demonstrated technical skills in the development and manufacturing of medical devices
- Good communication skills, both written and oral, and must be computer literate
- Knowledge of and experience in developing and manufacturing medical devices in conformance with FDA Quality System Regulation, ISO 13485, ISO 14971 and ISO 60601 requirements
- Knowledge of analytical tools and methods related to design, development, and manufacturing, including statistics, DOE, and the use of computer/software packages
- Understanding of continuous improvement methodologies including Lean and Six Sigma
- Must possess a high sense of urgency, initiative and common sense
- Must present a professional demeanor and demonstrate an ability to work effectively with a diverse group of individuals
- Must be energetic, work quickly and efficiently with detail and accuracy
- Must be able to effectively manage multiple priorities in a fast paced and dynamic environment
Hansen Medical, Inc. is an Equal Opportunity Employer.
Indeed - 17 months ago