Manufacturing Engineer

Manufacturing Engineer Location: EXALTA Group – Kenosha Reports To: Engineering Manager

Position Summary:

The Manufacturing Engineer applies engineering principles, technical expertise, and independent judgment to develop, validate, optimize, and continuously improve manufacturing processes for precision medical device components. The position develops and supports manufacturing process development, technical problem-solving, and continuous improvement initiatives to support product quality, manufacturability, cost efficiency, and operational performance. This role serves as the primary technical owner of quoting activities for new and existing businesses, evaluating manufacturing feasibility, process requirements, and cost considerations. The Manufacturing Engineer collaborates with Operations, Quality, Programming, R&D, customers, and suppliers to develop and implement effective manufacturing solutions.

Essential Duties and Responsibilities:

The responsibilities outlined below represent the general scope of the Manufacturing Engineer position. Specific assignments and areas of technical focus may vary based on business needs, individual expertise, and operational priorities. Employees may be assigned primary responsibility for certain functions while supporting other engineering activities.

• Lead technical quoting activities for new and existing business, including evaluating manufacturing feasibility, process requirements, tooling, equipment, and cost considerations using Epicor and Paperless Parts.
• Serve as the primary technical point of contact for quoting activities and assigned engineering projects, coordinating with customers, suppliers, and internal stakeholders.
• Lead manufacturing process development and validation activities, including process flows, risk assessments, PFMEAs, control plans, testing protocols, and IQ/OQ/PQ activities.
• Develop, document, and maintain manufacturing processes, work instructions, bills of materials (BOMs), and ERP routings in accordance with customer requirements and EXALTA procedures.
• Review customer specifications, engineering drawings, and orders to determine manufacturing requirements, product functionality, manufacturability, and inspection considerations.
• Evaluate, develop, and optimize manufacturing methods, equipment, tooling, and processes to improve quality, efficiency, cost, and production performance.
• Apply Lean Manufacturing principles and engineering analysis, including time studies, to identify waste, improve productivity, and reduce manufacturing costs and lead times.
• Collaborate with Programming and Operations to develop custom tooling, evaluate machining requirements, and identify appropriate tooling and equipment solutions.
• Provide technical oversight of subcontracted manufacturing processes and support supplier evaluations, process improvements, and audits in collaboration with Quality.
• Lead engineering investigations and provide technical support for manufacturing nonconformances, material review board (MRB) activities, customer complaints, and corrective and preventive actions (CAPAs).
• Serve as a technical resource for complex manufacturing issues, independently evaluating root causes and developing effective engineering solutions.
• Identify, evaluate, and justify capital equipment investments and manufacturing improvements based on operational needs, technical feasibility, and cost considerations.
• Lead cross-functional project planning and technical discussions to support new product introductions, process changes, and manufacturing improvements.
• Drive improvements in Epicor utilization, manufacturing engineering workflows, and the accuracy and consistency of engineering data.
• Provide technical guidance and support the development of engineering team members.
• Perform other duties as assigned.

Knowledge, Skills & Competencies:

• Strong knowledge of CNC machining, tooling, manufacturing processes, raw materials, and precision machining capabilities.
• Advanced ability to interpret engineering drawings, blueprints, geometric dimensioning and tolerancing (GD&T), and technical specifications.
• Demonstrated experience planning, developing, and executing process testing and validation activities for machining and secondary manufacturing processes.
• Proficiency in SolidWorks and machine shop mathematics.
• Strong analytical and problem-solving skills, including root cause analysis and experience implementing corrective and preventive actions (CAPAs).
• Proficiency in project planning, prioritization, and managing multiple projects, including leading process improvement initiatives.
• Strong understanding of Lean Manufacturing and/or Six Sigma methodologies.
• Ability to work independently and collaboratively with cross-functional teams to resolve technical challenges and achieve project objectives.
• Strong written and verbal communication skills, including the ability to effectively communicate technical information to internal and external stakeholders.
• Ability to manage competing priorities, meet deadlines, and navigate challenging situations professionally.
• Proficiency in Microsoft Office applications and other relevant business software.
• Experience in medical device manufacturing and knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements preferred.
• Knowledge of Statistical Process Control (SPC) preferred

Education, Certifications, and/or Licenses Requirements:

• Bachelor's degree preferred in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Engineering Technology, or a closely related technical discipline.
• Minimum of 5 years of relevant manufacturing engineering experience with a bachelor's degree, or 8 years of progressively responsible technical experience demonstrating engineering-level competencies in precision machining, manufacturing process development, and technical problem-solving in lieu of a degree.

Work Environment:

• The noise level in the work environment is usually moderate.
• Work environment consists of time spent in both an office (50%) and manufacturing environment (50%).
• Includes potential exposure to sound and noise levels that can be distracting or uncomfortable.
• Includes potential exposure to moving mechanical parts.
• Includes potential exposure to coolants and oils.
• Work environment is temperature controlled.

The work environment described here is representative of that which an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Job Requirements:

• While performing the duties of this job the employee is regularly required to sit, stand or walk; use hands, handle, or feel objects, tools or controls; reach with hands and arms; talk and hear.
• The employee must be able to lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus.
• The employee must be able to sit or stand for up to 12 hours per day.
• Ability to function in highly stressful situations.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

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.