Sr Manager, Manufacturing Engineering

Work ScheduleFirst Shift (Days)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, OfficeJob DescriptionPosition SummaryResponsible for strategically leading the Engineering function in a pipette micromolding, injection molding, blow molding, and assembly plant, with focus on capital projects, capacity expansions, plant sustainability, engineering changes and releases, as well as product and process validations and revalidations.This role ensures that engineering solutions support business objectives, regulatory compliance, and customer requirements, working in coordination with the Tool Room (molds) area, without direct operational responsibility over maintenance or Tool Room.Job Duties and General ResponsibilitiesEngineering Strategy and LeadershipDefine and execute engineering strategy aligned with site and division objectivesLead, mentor, and develop a high-performing engineering teamPromote a culture of continuous improvement, accountability, and complianceManage Engineering budget, including CAPEX planning and prioritizationProjects, Expansions, and SustainabilityLead capital projects (new molding technologies, automation, capacity expansion)Drive sustainability initiatives (energy efficiency, waste reduction, resource optimization)Coordinate layout planning, process flows, and line balancingEngineering Changes and ReleasesManage engineering changes (ECR/ECO)Evaluate impact on quality, validation, cost, and capacityApprove and release changes per quality and regulatory requirementsEnsure documentation is accurate, current, and controlledValidations and Regulatory ComplianceOwn the Validation Master PlanLead IQ/OQ/PQ, revalidations, and process qualificationsEnsure compliance with ISO 13485, ISO 9001, and applicable regulatory standardsNew Products and Customer RequirementsLead New Product Introduction (NPI) activitiesEnsure effective design transfer into manufacturingInterpret and implement customer specificationsCollaborate cross-functionally with Quality, Production, Supply Chain, and MaintenanceInteraction with Molding and Tool RoomOptimize molding processes, including micromolding, injection molding, and blow molding, focusing on precision, repeatability, and efficiencyCollaborate with Tool Room on mold design, maintenance strategies, and continuous improvementAct as a technical liaison between engineering and tooling functionsContinuous Improvement and MethodologiesPromote Lean / PPI methodologies and structured problem-solvingEnsure safety, ergonomics, and environmental compliancePeople Management and CultureEnsure adherence to Code of Conduct and company policiesConduct performance evaluations (PMD)Develop succession plans and foster talent growthMinimum RequirementsEducationBachelor’s degree in Engineering (Industrial, Mechanical, Mechatronics, Manufacturing, or related)Master’s degree (preferred)ExperienceMinimum of 10 years of experience leading and managing engineering organizations within molding manufacturing environmentsRecognized expertise in molding operations for medical devices and/or life sciences components, ensuring compliance with regulatory and quality standardsHands-on knowledge of micro-molding processes, including challenges related to precision, tooling, and process controlProven track record leading capital projects, capacity expansions, and New Product Introduction (NPI) in highly regulated environments (e.g., ISO 13485, FDA)Demonstrated ability to drive process optimization, scalability, and operational excellence in molding operationsLanguagesAdvanced EnglishAdditional Certifications (Preferred)PMPSix Sigma (Green/Black Belt)Lean ManufacturingCertified Quality Engineer (CQE)Specialized SkillsStrong expertise in precision molding technologies, particularly micromolding, with solid fundamentals in injection and/or blow moldingValidation methodologies (IQ/OQ/PQ)Experience in regulated environments (ISO 13485, FDA or similar)Project management and CAPEX planningEngineering change management (ECR/ECO)Data analysis and structured problem solving (Lean, Six Sigma)Cross-functional leadership and stakeholder managementStrategic thinking and decision-making