Manufacturing & Costing Engineer
- We are not currently working with third party agencies on this role.
- 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 such as ISO 9001.
- 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 wast
- Owns measurable KPIs such as cycle time, scrap reduction, cost savings, and process waste elimination, with accountability for demonstrating improvements tied to site cost and delivery performance.
- 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 (including IQ/OQ/PQ), processes, and material evaluations in alignment with ISO 9001, FDA, and other applicable regulatory standards.
- Ability to utilize CAD / CAM software for product review and fixture design.
- Develop costing for new business opportunities utilizing Visual Manufacturing ERP and Excel-based tools.
- Collaborates across Vantedge sites to align estimating and costing methodologies, ensuring consistency and standardization of CAD/CAM, cost models, and quote tools.
- Collaborates with company SMEs and cross-site teams 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.
- Obtains quotations for outside services and materials either by direct contact with suppliers or by requesting assistance of the Buyers.
- Reviews pricing and cost history and performs re-quotes.
- Engineering or bachelor’s degree in a technical field.
- 5+ years of work experience in similar technical roles including medical device or regulated industry manufacturing required.
- Understanding and experience in metals machining, sub-processing including welding and fabrication, assembly, and inspection is strongly preferred.
- Strong problem-solving skills.
- Ability to provide solid rationale and justification for process proposals and improvement change requests.
- Lean manufacturing and new product development or launch support experience is highly desirable.
- Ability to collaborate in a team environment.
- Strong written and oral communication skills.
- Experience in medical devices is preferred.
- Proficiency in Microsoft Office Suite.
- Working knowledge of ISO and FDA regulations and GD&T.
- Demonstrated ability to develop and execute process validations and documentation compliant with ISO 9001 and IQ/OQ/PQ standards.
- Experience leveraging CAD/CAM and cost modeling tools to drive data-driven estimating and cross-site standardization.
- Infrequent travel as needed for site visits, customer meetings, and industry events.
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