- This position is responsible for product design and development, including assembly drawings, part drawings, and other required documentation.
- Also includes heavy involvement in the establishment and documentation of manufacturing processes.
- Metal stampings, plastic injection molded components, and CNC machined components and clean room assembly are a necessary knowledge background.
- Involves a close interaction with internal and external design engineers and planners.
- Work closely with manufacturing engineering, manufacturing, and suppliers early in the conceptual and prototype phase to guide the development process for optimized cost and manufacturability.
- Design of tooling and fixturing.
- Development and implementation of the manufacturing assembly and test strategy of components, sub-assemblies and end products.
- Ensure all processes, tooling and equipment utilized in manufacturing have adequate documentation including but not limited to, quality and test plans, equipment functional specifications, system documentation, user guides (operation, calibration and maintenance), component/assembly drawings, Bill of Materials and purchase specifications. May require tooling and fixturing design.
- Participate in first article approval process.
- Participate in Failure Mode Effects and Analysis.
- Ensure ISO compliance as related to manufacturing process procedures, waivers, engineering change orders, equipment calibration and new product implementation.
- Develops assembly guides, procedures, and illustrations.
- Resolves manufacturing problems by applying technical knowledge and skills. Escalates design, manufacturing, and product test issues to others within the organization when appropriate.
- Participate in project teams in the development of medical and surgical products, which will include working with:
- Product Management to prepare a complete product specification
- Cost Engineering to prepare a product cost estimate
- Prototyping resources to create models for product design evaluation
- Quality Assurance to determine product reliability, function and testing parameters
- Operations to determine tooling and assembly requirements
- B.S. in Engineering or related technical discipline with 1-3 years of experience.
- The candidate must be highly motivated, hands-on, innovative, able to work with minimal direction, and should have good problem solving, teamwork, and strong oral and written communication skills. Must be comfortable speaking to all levels of the organization along with customers and vendors.
- Strong leadership and organizational skills with a demonstrated ability to lead cross-functional teams.
- Working experience with Solidworks or an equivalent CAD system is desired.
- Proficiency with Microsoft Office Applications (Excel, Word, and Outlook) is required.
- Knowledge of statistical techniques and the ability to plan and implement projects from concept to completion is desired.
- Knowledge of metal and plastic design requirements and fabrication techniques is required.
- Demonstrated success in leading Lean or Continuous Improvement activities.
- Knowledge of ISO quality systems where a high level of compliance is expected.
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