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This position is responsible for design, development, and maintenance of processes, equipment, and tooling, to ensure products can be manufactured repeatedly at desired cost targets and acceptable quality levels. Responsible for managing projects into manufacturing readiness stage through Product Development Process.
Key responsibilities include, but are not limited to:
- Collaborate with R&D Engineering to design, develop, analyze, troubleshoot processes and provide technical support during new product development, quality improvement, and sustaining operations.
- Develop best practices, routines, and process documentation and operating instructions.
- Manage and/or participate on cross functional teams to accomplish project specific goals.
- Present technical findings or project status to cross functional teams through meeting minutes, design reviews, presentations and other means of communication.
- Support the qualification of new parts/materials, and machine validation through FAI/capability analysis, or equivalent.
- Support the development, evaluation, improvement and documentation of manufacturing processes for repeatability that meet our quality, cost, cycle-time and safety needs (including process control techniques).
- Preparation of Capital Appropriation Requests (CAR’s).
- Create, release and manage Bill of Materials (BOM’s) and routers in ERP system.
- Preparation of cost models/estimates.
- Special projects as needed to support operations and our customers including those which require additional work hours, travel, and training.
- Maintain a thorough knowledge of new developments and technology.
- Bachelor’s degree in Biomedical or Mechanical Engineering.
- Project management experience.
- Demonstrated proficiency with SolidWorks/CAD.
- Strong problem solving, analytical and technical skills.
- Demonstrated proficiency with tool and fixture design.
- Creative thinker with well-developed interpersonal skills and effective communicator.
- High level of self-initiative and dependability.
- High energy level and drive to finish projects or issues.
Flexible schedule to accommodate fluctuations in customer deadlines.
- 5 + years of “hands-on” experience in a manufacturing environment.
- Programming experience, Labview highly preferred.
- Comprehensive knowledge of quality practices, tools, and specifications.
- Knowledge in BOM management working with JD Edwards or similar enterprise resource planning software.
- Familiar with ergonomic practices.
- Experience generating specifications, purchasing and qualification of equipment.
- Knowledge of Quality Management Systems and respective ISO standards.
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