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Director, Manufacturing Engineering
Insulet Corporation. Provide strategic and technical leadership for the Costa Rica greenfield site Manufacturing Engineering organization .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Manufacturing Engineering leadership, focusing on project management, process validation, and compliance within FDA-regulated environments. Proven ability to drive continuous improvement and operational excellence through data analysis and cross-functional collaboration.
Highest-signal resume keywords
Manufacturing Engineering LeadershipProcess Validation MethodologiesLean ManufacturingFinancial ManagementCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementProcess ValidationEquipment Lifecycle ManagementData AnalysisAutomation Process ExpertiseContinuous Improvement ToolsSafety ComplianceHigh-Volume ManufacturingRegulatory ComplianceMultidisciplinary Team Leadership
Soft Skills
Analytical Problem-SolvingCommunicationCoachingInfluenceTeam Development
Tools & Technologies
CMMSMESERPSPCSix SigmaQuality Management SystemAsset Management SystemsData Integration ToolsManufacturing Execution SystemsEquipment Design Tools
Certifications & Qualifications
Bachelor's Degree in EngineeringISO 13485 Knowledge
Industry Keywords
FDA-Regulated EnvironmentHigh-Volume ManufacturingCleanroom EnvironmentLife SciencesQuality Control Best PracticesRegulated IndustryManufacturing OperationsProcess Capability AnalysisProduction-Line Start-UpOperational Excellence
Tech Stack
Tools & technologiesAssemblyERP
About the role
Key responsibilities & impact- Provide strategic and technical leadership for the Costa Rica greenfield site Manufacturing Engineering organization
- Build, lead, coach, and develop multidisciplinary engineering teams
- Develop project, resource, and hiring plans for plant start-up, production ramp, capacity expansion, and ongoing operations
- Lead equipment design reviews, procurement, factory and site acceptance testing, installation, commissioning, qualification, process validation, and production-line start-up
- Own engineering performance indicators for safety, quality, service, cost, uptime, yield, line efficiency, maintenance, calibration, and project execution
- Establish and improve preventive maintenance, calibration, spare-parts, asset-management, and reliability strategies
- Drive data-based problem solving using SPC, process capability, root-cause analysis, Lean, Six Sigma, and mistake-proofing
- Ensure equipment, processes, facilities, and documentation comply with quality-system, regulatory, environmental, health, and safety requirements
- Partner with Operations, Quality, Regulatory, Supply Chain, Global Engineering, Finance, IT, and external suppliers
- Manage departmental CAPEX, OPEX, project budgets, resource allocation, cost improvement, and financial performance
- Support MES, CMMS, ERP, and equipment-data integration
- Build technical capability, succession plans, training systems, accountability, inclusion, continuous improvement, and operational excellence
- Serve as functional lead for Global Manufacturing Engineering resources and activities
- Act as Global Engineering subject matter expert for the Pod device
- Support validation activities including FAT, TMV, IQ, SAT, OQ, and PQ
- Coordinate cross-functional resources for production-line start-ups and PQ goals
- Resolve manufacturing process losses through product and process improvements
- Provide automation-process expertise
- Support DV builds, obsolescence programs, technology transfers, documentation, future DFM/Next Gen Pod development, equipment/process standardization, and KPI action planning
Requirements
What you’ll need- Bachelor’s degree in Manufacturing, Mechanical, Electrical, Industrial, or a related Engineering discipline required
- 10+ years of progressive experience in high-volume manufacturing, engineering, plant engineering, maintenance, automation, or related operations
- 7+ years of engineering leadership experience, including responsibility for building, developing, and leading multidisciplinary technical teams
- Experience with highly automated discrete-component assembly, equipment lifecycle management, production-line start-up, and manufacturing scale-up
- Working knowledge of equipment qualification and process-validation methodologies, including FAT, SAT, TMV, IQ, OQ, and PQ
- Experience in an FDA-regulated and ISO 13485 quality-system environment preferred
- Experience with CMMS, MES, enterprise asset management, ERP integration, Lean manufacturing, Six Sigma, SPC, and process-capability analysis preferred
- Strong financial management, business acumen, analytical problem-solving, communication, and cross-functional influence
- Able to work in a Class 8 cleanroom environment as needed
- Must be able to stand and walk up to 5 hours a day
- Must be able to flex work schedule regularly as business demands for shift coverage
- Bachelor’s Degree in Engineering
- 7+ years of management experience in a high-volume manufacturing environment, with at least 3+ years of departmental leadership
- Experience in a regulated industry required; life sciences preferred
- Knowledge of safety compliance with State, Federal, and Local regulations and manufacturing operations/quality-control best practices
- Ability to analyze data using various operating systems and programs
- Experience working collaboratively under a Quality Management System (QMS) preferred
- Experience with continuous-improvement tools and methods
- Domestic and international travel may be required up to 50% of the time
Benefits
Comp & perks- Remote type listed as Remote, but the role requires a minimum of four days per week in the office
- Travel up to 25%, including international travel to suppliers and manufacturing sites
- Travel may be required up to 50% of the time
- Support for continuous improvement, technology transfers, and future expansion activities
- Training systems, succession plans, and technical capability development opportunities