Job Description

The Manufacturing Engineer designs, builds, and maintains assembly tooling, processes, and assembly line layouts for current & new products, focusing on maximizing space and efficiency. Collaborates with other teams to ensure design of process and product supports quality and manufacturability requirements. Dynamically solves problems to drive production throughput to meet goals and ensure team and organizational success.

Job Duties & Responsibilities:

• Establish inspection methods, acceptance criteria, and sampling plans for newly outsourced components.
• Design gages and inspection fixtures.
• Recommend and implement changes and enhancements to existing manufacturing procedures at suppliers to improve the quality of products.
• Experience with control plans.
• Working knowledge of medical device regulations (FDA/ISO/DHF)
• Inspection techniques.
• Gage R&R & Bias.
• Evaluate and improve product prints for manufacturability while applying GD&T and dimensional stack-ups.
• Responsible for driving the Corrective Action and Preventive Action (CAPA) process.
• Evaluate and disposition components determined to be non-conforming, and drive suppliers to reduce non-conformance deliveries.
• Dimensional verification of incoming inspection results.
• Train Suppliers to effectively execute Supplier Corrective Action Requests (SCAR) and Corrective Actions Preventive Actions (CAPA).
• Provide expert consultation in one or more areas for the design, development and implementation of technical systems and manufacturing processes. Areas of expertise required include but are not limited to:
• Metal injection molding
• Plastic injection molding
• High volume CNC machining fixtures
• Gage design
• Machine/tool design
• Heat treatment of metals
• Metal finishing.
• Resolve quality issues related to product and processes using statistical methods.
• Keep track of open issues and drive all projects to closure.
• Other duties may be assigned.

Qualifications And Educational Requirements

• Bachelor’s Degree in Mechanical or Manufacturing Engineering and at least 5+ years of experience or 3-5 years of experience with trade apprenticeship or equivalent metal trades experience in a related field.
• In depth knowledge of Geometric Dimensioning and Tolerancing (GD&T) ASME Y14.5M-1994.
• Strong project management skills.
• Strong problem-solving skills.
• Proficiency with SolidWorks or similar CAD system.
• Ability to effectively communicate.
• Proficient in MS Office applications, such as Word, Excel, PowerPoint, etc.
• Detailed oriented with creative problem solving skills and the ability to drive resolution and closure.
• Familiarity of FDA is a plus
• Good working knowledge of materials and heat treating processes.
• Overall must be able to work in a team, lead, plan, and execute multiple projects. The quality of work must be very high. Written and verbal communication of complicated subjects is required. Organization of documentation and record keeping shall be to a high standard.

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