Title: Manufacturing Engineer (Medical Device)
Pay: $50.00 - $60.00/hour
Job Overview: The Manufacturing Engineer is a manufacturing and process development expert leading project work related to manufacturing integration of medical devices.This individual will be involved in all phases of product development as a key contributor representing manufacturing. You will work with R&D to ensure designs are manufacturable, evaluate potential suppliers, and work with internal and external teams to develop and validate manufacturing processes.
Process Development & Validation:
- Drive efforts to design, develop, validate, and continuously improve manufacturing processes.
- Develop & define production control methods to monitor process output and establish critical supplier metrics.
- Define and coordinate the design and development of manufacturing fixturing and test equipment.
- Coordinate with R&D at suitable stages to optimize the design for manufacturing and reliability.
- Perform or direct DOE, correlation studies and apply statistical analysis for product and process improvements.
- Lead and support manufacturing development and transfers to contract manufacturers.
Design Controls Documentation:
- Provide input to the User Requirements and System Requirements Documents.
- Ensure compliance to the requirements of ISO13485 standards, FDA regulations and Good Manufacturing Practice regarding process, design and development of new and existing products.
- Identify potential suppliers and perform technical evaluation for selection.
- Bachelor’s Degree in ME or EE or other relevant Engineering discipline
- 3-7 years of related design and manufacturing experience in the medical device and/or component industry
- Design Control experience including design and process verification and validation preferred
- Injection molding, die casting, tooling experience
- Experience in manufacturing and assembly process development and validation (IQ, OQ, PQ and PPQ)
- Thorough understanding of test method validation, GR&R, GD&T, and statistical analysis
- SolidWorks or CAD experience preferred
- Experience with Project Management
- Practical knowledge of Six Sigma, Green or Black Belt
- ISO Quality System requirements and FDA regulations knowledge required
- Mechanical and electromechanical experience
Key Skills: IQ, OQ, PQ, Design, Process Development, Validation, ISO 13485, Engineering, Manufacturing, Medical Device, Component, Solid Works, Process, R&D, Statistics, FDA, Electromechanical