Project Engineer

Duration: 12 Months

• Must have expertise in process validations (IQ/OQ/PQ) for medical device equipment and processes.
• 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 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.

Skills:

• 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.