Location
Newark, DE | United States
Job description
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.
Job tags
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