Job Description
Join our dynamic team in Warsaw, IN, a vibrant hub for manufacturing innovation, where you will play a crucial role in advancing our in-house production capabilities. As a Manufacturing Engineer, you will be instrumental in ensuring the seamless transition of manufacturing processes from external vendors to our internal production environment.
Position Summary
The Manufacturing Engineer is responsible for supporting the transfer of manufacturing processes from an external vendor to in-house production. This role will coordinate and execute key transfer activities to ensure a smooth, compliant, and efficient transition of products, processes, equipment, and documentation into the internal manufacturing environment. The engineer will work cross-functionally with Operations, Quality, Supply Chain, Product Development, Regulatory, and external partners to establish robust manufacturing processes that meet safety, quality, delivery, and cost objectives.
Key Responsibilities
- Lead and support manufacturing transfer activities from outside vendors to internal manufacturing sites.
- Develop and execute transfer plans, timelines, and readiness activities to support successful production launch.
- Evaluate existing supplier manufacturing processes, tooling, fixtures, equipment, process controls, and documentation for transfer suitability.
- Partner with cross-functional teams to define manufacturing requirements, capacity needs, equipment needs, and production flow for in-house manufacturing.
- Create, revise, and maintain manufacturing documentation including work instructions, routers, process flows, PFMEAs, control plans, equipment qualifications, validation protocols, and reports.
- Support process development, process characterization, and process validation activities including equipment IQ and Process OQ, and PQ, as applicable.
- Coordinate equipment installation, qualification, and implementation for transferred processes.
- Identify process risks and implement mitigation plans to ensure quality and continuity of supply.
- Troubleshoot manufacturing issues during transfer, pilot builds, and production ramp-up.
- Analyze manufacturing performance data and drive improvements in yield, cycle time, throughput, scrap reduction, and overall process capability.
- Ensure transferred processes comply with internal quality system requirements and applicable regulatory requirements.
- Collaborate with supplier quality and sourcing teams to support knowledge transfer, documentation handoff, and transition planning.
- Support training of production personnel and ensure manufacturing processes are released in a controlled and sustainable manner.
- Drive continuous improvement initiatives using Lean, Six Sigma, and root cause analysis methodologies.
- Support change control activities related to process transfer, equipment implementation, and documentation updates.
- Bachelor’s degree in Engineering discipline.
- Minimum of 3 to 5 years of engineering experience in manufacturing, process engineering, industrialization, or operations support.
- Experience supporting manufacturing transfer, process transfer, new product introduction, or supplier-to-site transfer activities.
- Knowledge of process validation, equipment qualification, and manufacturing documentation requirements.
- Experience working in a regulated industry such as medical device, pharmaceutical, aerospace, or similar.
- Strong problem-solving, project management, and cross-functional collaboration skills.
- Strong written and verbal communication skills.
- Ability to manage multiple priorities in a fast-paced manufacturing environment.
- Experience in medical device manufacturing.
- Familiarity with GMP, GDP, FDA, ISO 13485, and applicable regulatory requirements.
- Experience with risk management tools such as PFMEA and control plans.
- Experience with Lean manufacturing and continuous improvement methodologies.
- Knowledge of statistical methods, process capability, and data analysis tools.
- Experience with ERP/MRP systems and manufacturing execution systems.
- Six Sigma certification or formal continuous improvement training.
- Experience supporting pilot builds, line set-up, and production ramp.
- Technical leadership
- Manufacturing process development
- Project execution
- Cross-functional collaboration
- Risk identification and mitigation
- Problem solving and root cause analysis
- Documentation and change management
- Continuous improvement mindset
Years’Experience Required: 3-5 years of relevant experience providing manufacturing transfer support
Work Schedule: 40 hours a week, onsite
Interview Timeline: ASAP
Product Line Support: This position is not product specific. The project covers multiple product lines.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Staffing/Employment Agencies |
| Salary | $40 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Aerospace and Defenseunmatched
- Biotech and Pharmaceuticalunmatched
- Capacity Requirements Planning (CRP)unmatched
- Change Controlunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Document Change Managementunmatched
- Document Managementunmatched
- Documentationunmatched
- ERP (Enterprise Resource Planning)unmatched
- Engineeringunmatched
- Equipment Validationunmatched
- FDA (Food and Drug Administration)unmatched
- GMP (Good Manufacturing Practices)unmatched
- ISO (International Organization for Standardization)unmatched
- Identify Issuesunmatched
- Knowledge Transferunmatched
- Lean Manufacturingunmatched
- Lean Six Sigmaunmatched
- Manufacturingunmatched
- Manufacturing Analysisunmatched
- Manufacturing Engineeringunmatched
- Manufacturing Execution Systems (MES)unmatched
- Manufacturing Process Engineeringunmatched
- Manufacturing Requirementsunmatched
- Manufacturing Systemsunmatched
- Manufacturing/Industrial Processesunmatched
- Medical Equipmentunmatched
- Multitaskingunmatched
- Network Routersunmatched
- Operational Supportunmatched
- Performance Analysisunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Process Capabilityunmatched
- Process Control Engineeringunmatched
- Process Developmentunmatched
- Process Failure Mode and Effects Analysis (PFMEA)unmatched
- Process Flowunmatched
- Process Improvementunmatched
- Process Validationunmatched
- Product Developmentunmatched
- Product Supportunmatched
- Product/Service Launchunmatched
- Production Supportunmatched
- Production Systemsunmatched
- Productivity Managementunmatched
- Project Executionunmatched
- Project/Program Managementunmatched
- Quality System Requirements (QSR)unmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Requirements Managementunmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Root Cause Analysisunmatched
- Safety Processunmatched
- Safety/Work Safetyunmatched
- Six Sigma Certificationunmatched
- Staff Trainingunmatched
- Supply Chainunmatched
- Team Playerunmatched
- Technical Leadershipunmatched
- Tool and Die Manufacturingunmatched
- Validation Planunmatched
- Vendor/Supplier Evaluationunmatched
- Vendor/Supplier Sourcingunmatched
- Writing Skillsunmatched
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