Job ID 210000AN
Available Openings 1
As a key member of the Quality Team, the incumbent will support quality activities related to the design, development, and reliability of NxStage Medical's products. The systems DA engineer considers requirements of all disciplines that make up a product, including interactions of mechanical/electrical, disposables, software, and fluids for proper use of the system, and may collaborate with design assurance subject matter experts for specific parts of the program. The role is deeply rooted in design control practices and compliance. Influence, collaboration, and self-awareness are key soft skills for the position.
• Provide technical and statistical reliability support to Product Development, Manufacturing and Quality organizations
• Lead major efforts, or phases of projects, to resolve advanced and complex technical and Quality-related problems Contribute to New Product Introduction Projects as a core team member and communicate activities to the extended team members of Quality
• Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies
• Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed
• Lead/support Risk Management activities to ensure design and process shortcomings are identified and appropriately addressed
• Monitor and develop reliability improvements to existing & new designs
• Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence
• Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP's, QSR 21 CFR Part 820 and ISO 13485
• Evaluate quality data and prepare periodic reports to monitor trends.
• Generate, review and approve Engineering and Development Change Orders for Design Assurance and support major design changes to existing products
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor's Degree required; Advanced Degree desirable
EXPERIENCE AND REQUIRED SKILLS:
7+ years Design Assurance/Quality Engineering or similar engineering experience in the Medical Device Industry
• ASQ Certification(s) and exposure to Six Sigma techniques a plus.
• Knowledge of and practice with FDA Quality System Regulation 21 CFR Part 820 and ISO13485 required, in particular Design Control requirements.
• Knowledge of and practice with risk management tools and techniques. FMEAs, FTAs, ISO 14971 risk management standard.
• Knowledge of and practice with Design Validation and Design Verification tools and techniques
• Excellent verbal communication and technical writing skills
• Ability to interface with multiple groups in the organization
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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