The New Product Introduction Engineer will be responsible
for the support of mechanical and opto-mechanical designs from Engineering to Manufacturing on new products.
• Design mechanical and opto-mechanical components and assemblies for medical lasers.
• Support transfer of mechanical and opto-mechanical designs from Engineering to Manufacturing.
• Review proposed mechanical designs to ensure fit with mating part, proper dimensioning and tolerance and proper manufacturing methods.
• Identify critical dimensions on custom components.
• Evaluate existing designs and recommended alternative methods of manufacturing raw materials (i.e. sheet metal, molded plastic components, precision machined parts), to minimize cost while maintaining a high level of mechanical integrity.
• Develop quality dashboard to highlight/reduce/eliminate product failures in the design phase.
• Responsible for continual improvement activities to enhance the quality system for new designs, ensuring best practices are developed and driven through the design of new products.
• Cost and TAKT time goals are meet for newly designed products
• DFMEA/PFMEA analysis completed and controls implemented to reduce the chance of poor Quality
• Interface with Engineering and Operations to ensure products are in accordance with approved data.
(Drawings are detailed with Critical characterizes and PPAPs are completed for qualification)
• Proficient in Microsoft Office, specifically Access, Excel, and Word
• Conduct capability studies on new products, including Gage R&R
• Bill of materials
• Selection and qualification of Suppliers and their processes
• Component specifications
• Hazard and Risk Analysis documentation
• Equipment and Fixture Design
• Development of manufacturing processes and instructions
• Master Validation Plans
• Control Plans
• Manufacturing Equipment validation protocols and test reports (IQ/OQ/PQ)
• Manufacturing Process validation protocols and test reports
• Packaging Process validation protocols and test reports
• Shipping and distribution validation protocols and test reports
• Other Regulatory/Compliance documentation or activities as needed
• Ensure that all products/processes to be developed comply with GMPs, FDA, and other regulatory standards/guidelines as well as company SOPs.
• Manage and prepare documentation for the transfer to manufacturing of products
Essential Skills to be a top contributor in this role:
• 8+ years of directly related experience in a regulated industry.
• Bachelor of Science Engineering or significant work experience related to design for manufacturability.
• Master’s Degree in engineering preferred.
• Intimate familiarity with sheet metal fabrication, injection molding, precision machining and mechanical and opto-mechanical assembly processes.