New Product Introduction Engineer

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Finish Line Staffing Services Published: December 2, 2019
Marlboro, MA, United States
Job Type


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.

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