Senior Manufacturing Engineer

Senior Manufacturing Engineer

Location: EXALTA Group - Bonita Springs, FL
Reports To: Engineering Manager

Position Summary:

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.

This 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 Senior Manufacturing Engineer evaluates manufacturing methods, equipment, tooling, materials, and process performance to develop solutions that improve quality, efficiency, manufacturability, cost, and operational performance.

The role also provides technical leadership and mentorship to engineering personnel and serves as a key engineering resource for Operations, Quality, R&D, customers, and suppliers.

Essential Duties and 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 necessary to establish and maintain robust manufacturing processes.
• Review customer orders, drawings, specifications, and technical requirements and determine appropriate manufacturing methods and processing requirements to produce 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 the 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 by applying advanced 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 continuous-improvement initiatives that reduce waste, product cost, and lead time while maintaining or improving product quality.
• Develop and review engineering drawings, BOMs, 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 regarding manufacturing methods, validation, equipment, tooling, and problem resolution.
• Participate in and provide senior engineering input during design reviews with R&D teams, customers, Quality, and Operations.
• Provide recommendations regarding manufacturability, manufacturing processes, validation, materials, tooling, equipment, and process capability.
• Participate in supplier audits with Quality and evaluate manufacturing processes and engineering controls to determine whether applicable technical and quality requirements are met.
• Lead the engineering development and implementation of manufacturing processes for new products and customer orders from concept through production, including manufacturing feasibility, equipment, tooling, validation, and process requirements.
• Develop and maintain product and manufacturing data necessary to support appropriate internal and external manufacturing strategies.
• Conduct and analyze time studies, process data, and manufacturing performance information to identify and implement continuous-improvement opportunities.
• Partner with Programming and Manufacturing to develop and design custom tooling required for machining operations and determine appropriate tooling solutions based on engineering and manufacturing requirements.
• Evaluate subcontractor manufacturing processes for technical capability, efficiency, quality, and process effectiveness and recommend improvements based on engineering analysis.
• Provide engineering analysis and technical input to support quoting activities, including manufacturing methods, tooling, equipment, process requirements, and technical feasibility.
• Serve as a manufacturing engineering process owner for continued improvement and effective utilization of Epicor.
• Provide engineering expertise to the Material Review Board for nonconforming products, including technical evaluation, root-cause analysis and development of appropriate engineering solutions.
• Evaluate manufacturing capacity, capability, and process performance and 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, applying root-cause analysis and engineering judgment to develop and implement appropriate 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 appropriate 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.

Knowledge, Skills & Competencies

• Minimum of 7 years of progressive Manufacturing Engineering experience, preferably in a precision machining, production, or product-design environment.
• 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 appropriate solutions.
• Demonstrated experience leading complex engineering projects and manufacturing/process-improvement initiatives.
• Experience in a medical-device manufacturing environment preferred.
• 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 ISO 13485 and FDA 21 CFR Part 820 requirements preferred.
• Experience with CAPA, complaint investigations, nonconforming product, and root-cause analysis.
• Strong analytical and critical-thinking skills with the ability to evaluate complex technical information, assess alternatives, identify risk, and develop 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 with the ability to independently prioritize and manage multiple complex engineering projects.
• Ability to work effectively both 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.

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.