Senior Manufacturing Engineer
About The Position
The Senior Manufacturing Engineer leads the development, validation, and continuous improvement of manufacturing processes for precision medical device components and assemblies, taking projects from quote and concept through production. The role leads and develops Manufacturing Engineering personnel, owns quoting activities for new and existing business, and serves as the senior technical point of contact for Operations, Quality, R&D, customers, and suppliers. The position is based at EXALTA Group – Kenosha and reports to the Engineering Manager. Work is performed approximately 50% in an office and 50% in manufacturing environments. The environment is generally temperature controlled, with moderate noise and potential exposure to moving mechanical equipment, manufacturing machinery, coolants, oils, and other conditions typical of machining and manufacturing. The role regularly involves sitting, standing, or walking; handling objects, tools, or controls; reaching; communicating verbally; and hearing. It may require lifting or moving up to 50 pounds and extended periods of sitting or standing. Close, distance, peripheral, and depth vision, as well as the ability to adjust focus, are required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requirements
- At least 7 years of progressive Manufacturing Engineering experience in a precision machining or production environment, including experience leading or supervising engineers or technical personnel.
- Demonstrated experience preparing quotes for machined components or assemblies, including cost, cycle-time, and tooling estimates.
- Strong knowledge of CNC machining, tooling, machine-shop mathematics, and process validation (IQ/OQ/PQ).
- Advanced blueprint reading and GD&T skills; working knowledge of SPC.
- Experience with CAPA, complaint investigations, nonconforming product, and root-cause analysis.
- Working knowledge of Lean Manufacturing and/or Six Sigma.
- Strong project-management skills and ability to manage multiple complex projects and competing priorities in a fast-paced environment.
- Clear and effective communication with Engineering, Operations, Quality, leadership, customers, and suppliers.
- Proficiency in SolidWorks, Microsoft Office, and ERP systems; Epicor is preferred.
- Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or another closely related engineering discipline.
- Regularly sit, stand, or walk; use hands to handle objects, tools, or controls; reach with hands and arms; communicate verbally; and hear.
- May be required to lift and/or move up to 50 pounds.
- Requires close, distance, peripheral, and depth vision and the ability to adjust focus.
- May require extended periods of sitting or standing based on operational and manufacturing needs.
Nice To Haves
- Medical device experience, including ISO 13485 and FDA 21 CFR Part 820.
- Advanced engineering, Lean Manufacturing, Six Sigma, project management, or related certifications.
Responsibilities
- Lead, supervise, and develop Manufacturing Engineers and other technical personnel, including assigning work, setting priorities, coaching, and supporting performance management.
- Lead quoting for new and existing business by reviewing customer drawings, specifications, and requirements and defining manufacturing methods, routings, tooling, equipment, cycle times, and costs.
- Lead manufacturing engineering projects from concept through production as the technical point of contact for customer and internal programs, facilitating cross-functional meetings to drive completion.
- Develop, implement, and improve manufacturing processes, routings, methods, tooling, and equipment, including custom tooling in partnership with Programming and Manufacturing.
- Create and maintain PFPs, PFMEAs, Control Plans, drawings, BOMs, and routings in Epicor, serving as the Manufacturing Engineering process owner for the system.
- Lead machine and secondary-process validations (IQ/OQ/PQ) and develop test protocols with R&D, Quality, and Manufacturing.
- Provide manufacturability input in design reviews with R&D, customers, Quality, and Operations, evaluating drawings for function, tolerances, inspection requirements, and risk.
- Apply Lean and Six Sigma methods, time studies, and process data to reduce waste, cost, and lead time while improving quality.
- Evaluate capacity, capability, and process performance, and justify new equipment, tooling, or manufacturing technologies.
- Lead engineering support for CAPAs, customer complaints, and Material Review Board dispositions, using root-cause analysis to implement corrective and preventive actions.
- Evaluate suppliers and subcontractors for technical capability and quality, and participate in supplier audits with Quality.
- Standardize engineering practices and documentation across the organization and partner with Engineering leadership on departmental priorities.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
