Senior Manufacturing & Costing Engineer jobs in United States
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Vantedge Medical ยท 1 month ago

Senior Manufacturing & Costing Engineer

Vantedge Medical is the premier metals-based med-tech solutions partner specializing in the development and manufacturing of vital components for medical markets. The Senior Manufacturing & Costing Engineer will lead process and new product quote development, applying high-level engineering principles to drive improvements in manufacturing processes and costing for medical devices.

ManufacturingMedicalMedical Device
Hiring Manager
Cecily Nordstrom
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Responsibilities

Adheres to all safety and quality requirements including but not limited to: Quality Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements
Creates and implements lean processes in a cellular environment utilizing appropriate methods such as metals machining, sheet metal fabrication, and sub-processing such as assembly, powder coat, and metal finishing, welding, laser cutting, and electrical harness assembly
Performs root cause analysis to identify and implement needed process improvements eliminating waste
Defines, produces and implements documents including standard work and process work instructions
Identifies, develops, justifies, and executes detailed project plans for engineering work with minimum supervision
Ability to launch new products effectively in a contract manufacturing environment
Investigates, develops and implements new process technologies
Successfully communicates complex issues with customers and internal team members
Creates, reviews and approves engineering drawings, equipment layouts, change orders and specifications
Develops tooling, fixtures and equipment used in manufacturing to optimize productivity and cost
Effectively owns and manages CAPAs pertaining to their areas of responsibility
Collaborates with development, programmers, machinists and suppliers to evaluate designs for manufacturability and cost reduction
Creates and executes validation protocols, processes and material evaluations
Develop costing for new business opportunities across multiple sites to support small-format machining
Collaborate with company SMEs to determine optimal approaches for processes, machine cycle times, equipment selection, fixture design, and automation
Identify, document and communicate to the customer DFM opportunities to positively impact cost, quality, and delivery
Partner with Commercial to provide technical support when delivering customer proposals to build confidence in the manufacturing process quoted
Investigates new technologies and capabilities, with a focus on improving competitiveness in cost structure to increase value to customers and our business
Plan and execute projects, with minimum supervision, on time and within budget to achieve tangible results
Drive improvements through root cause analysis and data driven decision-making
Participates in cross-functional project teams to propose and implement creative solutions
Ensure internal and external customer expectations are met or exceeded
Develop accurate quotes with a strategic mindset of how to best serve the customer and the business
Manage assigned quotes to ensure timely completion
Supports other Vantedge Network locations in scope of similar technologies

Qualification

Medical device manufacturingLean manufacturingRoot cause analysisMetals machiningNew product developmentISOFDA regulationsWrittenMicrosoft Office SuiteGD&T knowledgeProblem-solving skillsTeam collaborationOral communication

Required

Engineering or bachelor's degree in a technical field
7+ years of work experience in similar technical roles including medical device manufacturing required
Strong problem-solving skills
Ability to provide solid rational and justification for process proposals and improvement change requests
Ability to collaborate in a team environment
Strong written and oral communication skills
Proficiency in Microsoft Office Suite
Working knowledge of ISO and FDA regulations and GD&T

Preferred

Lean manufacturing and new product development or launch support experience is highly desirable
Understanding of metals machining, sub-processing, assembly, and inspection is strongly preferred
Experience in medical devices is preferred

Company

Vantedge Medical

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Vantedge Medical offers medical equipment manufacturing services.

Funding

Current Stage
Late Stage

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