Senior Manufacturing Engineer

Senior Manufacturing Engineer

Location: EXALTA Group – Kenosha

Reports To: Engineering Manager

Position Summary:

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.

This 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. Essential Duties and Responsibilities

• Lead, supervise, and develop Manufacturing Engineers and other technical personnel, including assigning work, setting priorities, coaching, and supporting performance management.
• Lead quoting activities for new and existing business, reviewing customer drawings, specifications, and requirements to define 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 projects to 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, applying 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.

Knowledge, Skills & Competencies

• 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.
• Medical device experience, including ISO 13485 and FDA 21 CFR Part 820, preferred.
• Strong knowledge of CNC machining, tooling, machine-shop mathematics, and process validation (IQ/OQ/PQ).
• Advanced blueprint reading and GD&T; 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, with the ability to manage multiple complex projects and competing priorities in a fast-paced environment.
• Clear, effective communicator with Engineering, Operations, Quality, leadership, customers, and suppliers.
• Proficiency in SolidWorks, Microsoft Office, and ERP systems (Epicor preferred).

Education, Certifications, and/or License Requirements

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or another closely related engineering discipline required.
• Advanced engineering, Lean Manufacturing, Six Sigma, project management, or related certifications preferred.

Work Environment

• Work is performed in both office and manufacturing environments, approximately 50% in each.
• The noise level in the work environment is generally moderate.
• The position may be exposed to moving mechanical equipment, manufacturing machinery, coolants, oils, and other conditions typical of a machining/manufacturing environment.
• The work environment is generally temperature controlled.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

Physical Job Requirements

• Regularly required to 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.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

Why Join EXALTA?

At EXALTA, we partner with leading medical technology companies to bring life-changing products to market. You will play a key role in building a culture of continuous improvement, enabling scalable growth, and helping deliver our mission: Together, we make MedTech better.

EXALTA is an Equal Opportunity Employer. We respect every employee as an individual, and we hire and promote based on qualifications, performance, and potential - without regard to race, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.