What are the responsibilities and job description for the Project Engineer position at Oxenham Group LLC?
Job Summary
Our client seeks a Contract Engineer to support manufacturing operations and improve medical disposable products. This role involves IQ/OQ/PQ activities, risk management, process development, training, and LEAN implementation in medical product manufacturing.
Essential Duties & Responsibilities
- Implement verification and validation activities.
- Adhere to project schedules.
- Facilitate project plans and risk analysis, implementing solutions.
- Design manufacturing jigs, fixtures, and equipment.
- Develop work instructions and internal label specifications.
- Process document change orders (DCOs) accurately and promptly.
- Support manufacturing to meet quality standards, cost targets, and schedules.
- Develop safe, mistake-proof processes with clear instructions.
- Assist purchasing with documentation and vendor qualification.
- Perform failure analysis, corrective, and preventive actions.
- Provide cost and expense information to accounting.
- Additional duties as assigned.
Education & Experience Requirements
- Bachelor's Degree in Manufacturing or Process Engineering OR equivalent experience.
- Medical device industry experience.
- Proficiency in Microsoft Word, Excel, PowerPoint, Project, SolidWorks, and Minitab.
- Knowledge of Lean Manufacturing, packaging, labeling, cleanroom, and sterilization processes.
- Experience with semi-automated equipment implementation, including quotes, design inputs, and validations (FAT, SAT, IQ, OQ, PQ).
- Knowledge of materials selection, biocompatibility (ISO 10993), and design for manufacturing.
- Familiarity with FDA and ISO design control regulations.
Preferred Skills & Abilities
- Strong communication and organizational skills.
- Mechanical aptitude for equipment installation, repair, and maintenance.