• Identify, order and install manufacturing line equipment for a new product launch
• Responsible for setting up assembly procedures and test methods on a new manufacturing line.
• Conduct process analyses and use statistical techniques and risk-based decisions to analyze data. Prioritize and leads activities such as defect reviews, Kaizen events and process enhancement activities aimed at improving quality, reducing cycle time, and reducing cost.
• Develops, writes, and executes process validations (IQ/OQ/PQ) on manufacturing processes and in process test equipment for capital medical device equipment.
• Acts with urgency to identify, diagnose, prioritize, and resolve project and technical issues as they relate to validations and risk mitigations.
• Work with Manufacturing to ensure assembly procedures and manufacturing test procedures are validation ready.
• Create and manage Engineering Change Order documentation including validation data, protocols and reports within ***'s Quality Management system.
• Create additional manufacturing documentation as needed to support New Product Introductions.
• Interact with team leader on project status and resolution of critical issues; Promptly escalate unresolved dependencies and issues, which affect product delivery and quality that are beyond scope of influence.
• Drives the identification of critical to quality attributes and ensures component designs work together to fulfill manufacturing requirements. Provides Design for Manufacturability and Design for Assembly recommendations to the design team.
• Position based on-site in Newark, Delaware. Requires up to 25% travel to *** site in Danbury, Connecticut.

Requirements :

• Requires a bachelor's degree and 6 or more years of experience in the field or in a related area.
• Advanced knowledge of ERP Systems, MS Office, Solidworks.
• Comprehensive knowledge of knowledge of manufacturing, quality improvement and cost reduction methodologies such as CIMs, Lean, Root Cause and Root Cause Failure Analysis TQM, SPC and Six Sigma
• Excellent written and verbal communication skills. Adapts communication style to suite different audiences. Creates precise, accurate technical documentation. Able to facilitate group discussions.
• Strong contributor to high performing team
• Understanding of medical device compliance, standards, and regulations
• Knowledge of IPC, ANSI, and GD&T standards including ISO/ANSI 9001, ANSI/ASME Y14.1, ANSI/NFPA 79
• Knowledge of electrical circuits, and/or programming languages such as C/C /.net, LabVIEW, Visual Basic and/or PLC programming
• Ability to meet project deadlines and fluidly transition between multiple simultaneous projects.
• Familiarity with project management principles