Pay: $35.00 - $40.00/hour
Contributes to equipment projects and manufacturing process improvements. Provides insight and contributes to production reliability. Participates as a team member for technical operations sections of product development projects, including scale-up and production line design. Leads process development and equipment projects while maintaining schedules and meeting budgets. Success is measured through implementation of projects that meet desired outcome, budget, timeline, and manufacturing goals.
- Coordinates implementation of manufacturing equipment, process expansions, and new initiatives. Includes contribution to project budgets, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation.
- Assigns project tasks to the Engineering Technicians as appropriate.
- Respond to production interruptions and establish risk mitigations. Troubleshoot equipment and processing issues in support of production goals. Determine calibration and maintenance needs of new equipment.
- Establish new product costs, develop and implement necessary SOP’s, and establish processing, packaging and test specifications for products and equipment.
- Maintain project time lines and plans, accelerating where possible. In cooperation with management, create project and/or capital budgets to meet department budgets.
- B.S. in Mechanical Engineering, Biomedical Engineering, or related discipline.
- Minimum 5+ years of medical device or pharmaceutical process experience.
- Class III medical device or pharmaceutical experience.
- Experience with cleanroom environmental needs as related to equipment and processing, specifically autoclave sterilization and water systems.
- Demonstrated knowledge of ISO 13485, medical device regulations, FDA, and other Quality system environments.
- Solidworks and/or AutoCAD software.
- Ability to formulate program strategy, budgets, and timelines.
- Six Sigma Methodologies.
- Statistical Analysis.
- Demonstrated creativity and problem-solving skills.