Senior Manufacturing Engineer

Exalta Group • Bonita Springs, FL

26d • Onsite

About The Position

The Senior Manufacturing Engineer applies advanced engineering principles, technical expertise, independent judgment, and analytical problem-solving to develop, design, validate, and continuously improve manufacturing processes for precision components and assemblies. The position serves as a senior technical resource within Manufacturing Engineering, leading complex engineering projects from concept through production, resolving challenging manufacturing issues, and providing technical guidance to engineers and cross-functional teams. The role evaluates manufacturing methods, equipment, tooling, materials, and process performance to improve quality, efficiency, manufacturability, cost, and operational performance.

The Senior Manufacturing Engineer provides technical leadership and mentorship to engineering personnel and serves as a key engineering resource for Operations, Quality, R&D, customers, and suppliers. The position leads process development and validation, continuous improvement, technical project management, manufacturing investigations, and engineering support for new products, customer orders, and production operations.

The position is based at EXALTA Group in Bonita Springs, Florida, reports to the Engineering Manager, and is performed approximately 50% in office and 50% in manufacturing environments. The work environment is generally temperature controlled with moderate noise and may include exposure to moving mechanical equipment, manufacturing machinery, coolants, oils, and other conditions typical of machining and manufacturing.

Requirements

• At least 7 years of progressive Manufacturing Engineering experience, preferably in a precision machining, production, or product-design environment.
• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or another closely related engineering discipline.
• Advanced knowledge of engineering principles, manufacturing methods, process design, equipment, tooling, materials, and quality systems.
• Demonstrated ability to exercise independent technical judgment in evaluating complex engineering and manufacturing problems and developing solutions.
• Demonstrated experience leading complex engineering projects and manufacturing or process-improvement initiatives.
• Strong experience planning, developing, executing, and evaluating machine and secondary-process validations.
• Extensive knowledge of CNC machining, tooling, manufacturing processes, and machining capabilities.
• Advanced knowledge and interpretation of engineering drawings, blueprints, tolerances, and GD&T.
• Working knowledge of Statistical Process Control (SPC).
• Strong knowledge of machine-shop mathematics and manufacturing principles.
• Experience with CAPA, complaint investigations, nonconforming product, and root-cause analysis.
• Strong analytical and critical-thinking skills, including evaluating complex technical information, assessing alternatives, identifying risk, and developing engineering solutions.
• Demonstrated ability to provide technical leadership and mentorship to engineers and technical personnel.
• Ability to communicate complex technical information effectively with Engineering, Quality, Operations, leadership, customers, and suppliers.
• Strong project-management skills, including independently prioritizing and managing multiple complex engineering projects.
• Ability to work effectively independently and within cross-functional teams.
• Ability to manage competing priorities and resolve technical challenges in a fast-paced manufacturing environment.
• Proficiency in SolidWorks.
• Proficiency in Microsoft Office and applicable ERP systems.
• Strong understanding of Lean Manufacturing and/or Six Sigma methodologies.
• Strong customer-service and communication skills with internal and external customers.
• 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

• Experience in a medical-device manufacturing environment.
• Experience with ISO 13485 and FDA 21 CFR Part 820 requirements.
• Advanced engineering, Lean Manufacturing, Six Sigma, project management, or related certifications.

Responsibilities

• Serve as a senior technical resource and subject-matter expert for manufacturing processes, machining, tooling, equipment, validation, and process improvement.
• Lead complex manufacturing engineering projects from concept through production, establishing technical requirements, priorities, project plans, and engineering solutions.
• Apply advanced engineering principles and independent technical judgment to develop, evaluate, and improve manufacturing processes, routings, methods, tooling, and equipment.
• Serve as project manager and technical engineering point of contact for assigned customer and internal projects, independently evaluating technical requirements, risks, and manufacturing solutions.
• Develop and implement PFPs, PFMEAs, Control Plans, and other engineering documentation needed to establish and maintain robust manufacturing processes.
• Review customer orders, drawings, specifications, and technical requirements and determine manufacturing methods and processing requirements for cost-effective, conforming components and assemblies.
• Research, analyze, design, modify, test, and implement manufacturing methods and equipment consistent with customer quality agreements and company procedures.
• Lead development and execution of machine and secondary-process validations, including IQ, OQ, and PQ activities, as applicable.
• Develop testing protocols in collaboration with R&D, Quality, Manufacturing, and other engineering functions.
• Evaluate and improve manufacturing processes using knowledge of product design, fabrication, machining, assembly, tooling, materials, and quality requirements.
• Apply Lean Manufacturing and Six Sigma methodologies to analyze manufacturing performance and lead initiatives that reduce waste, product cost, and lead time while maintaining or improving product quality.
• Develop and review engineering drawings, bills of materials, manufacturing routings, and technical documentation within the ERP system.
• Analyze engineering drawings for product functionality, manufacturability, inspection requirements, tolerances, and manufacturing risk.
• Provide technical evaluation and engineering oversight of suppliers and manufacturing vendors.
• Provide technical guidance and mentorship to Manufacturing Engineers and other technical personnel on manufacturing methods, validation, equipment, tooling, and problem resolution.
• Participate in design reviews with R&D teams, customers, Quality, and Operations, providing senior engineering input and recommendations on manufacturability, processes, validation, materials, tooling, equipment, and process capability.
• Participate in supplier audits with Quality and evaluate manufacturing processes and engineering controls against applicable technical and quality requirements.
• Lead engineering development and implementation of manufacturing processes for new products and customer orders from concept through production, including feasibility, equipment, tooling, validation, and process requirements.
• Develop and maintain product and manufacturing data supporting appropriate internal and external manufacturing strategies.
• Conduct and analyze time studies, process data, and manufacturing performance information to identify and implement improvement opportunities.
• Partner with Programming and Manufacturing to develop and design custom tooling for machining operations and determine appropriate tooling solutions.
• Evaluate subcontractor manufacturing processes for technical capability, efficiency, quality, and effectiveness, and recommend improvements based on engineering analysis.
• Provide engineering analysis and technical input for quoting activities, including manufacturing methods, tooling, equipment, process requirements, and technical feasibility.
• Serve as a manufacturing engineering process owner for continuous improvement and effective utilization of Epicor.
• Provide engineering expertise to the Material Review Board for nonconforming products, including technical evaluation, root-cause analysis, and engineering solutions.
• Evaluate manufacturing capacity, capability, and process performance; identify, recommend, and technically justify new equipment, tooling, or manufacturing technologies.
• Provide engineering support for customer complaints and technical product investigations.
• Lead and support CAPA and complaint investigations involving engineering, subcontractor, or manufacturing issues, using root-cause analysis to develop and implement corrective and preventive actions.
• Facilitate cross-functional technical and project meetings to establish priorities, resolve engineering issues, manage project requirements, and drive projects toward completion.
• Serve as the senior engineering point of contact for complex manufacturing issues, independently analyzing problems and developing technical solutions.
• Mentor and support the technical development of Manufacturing Engineers and other technical team members, promoting engineering best practices and knowledge sharing.
• Identify opportunities to standardize and improve engineering practices, manufacturing processes, documentation, and technical methodologies across the organization.
• Partner with Engineering leadership to support departmental priorities, technical initiatives, and continuous-improvement objectives.
• Perform other professional engineering responsibilities consistent with the scope and senior level of the position.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior