Manufacturing engineer

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceJob PurposeTo support the engineering, implementation, and transfer of capable and effective manufacturing processes for a hydrogel-based medical device product, contributing to successful process transfer, facility start-up, and sustained commercial manufacturing.Key ResponsibilitiesTechnology Transfer & Process DevelopmentSupport assigned activities associated with the transfer of hydrogel/polymer-based manufacturing processes into the site.Assist in documenting current-state and future-state manufacturing processes, unit operations, process flows, and process inputs/outputs.Support translation of process knowledge into GMP-compliant manufacturing documentation, standard work, and process controls.Assist with process characterisation, process mapping, and capability assessment activities under guidance from more senior engineers.Collect, compile, and organise process data to support technical reviews, decision-making, and project discussions.Participate in project planning and execution activities for product/process transfer, facility start-up, and production readiness.Equipment Engineering & ValidationSupport installation, commissioning, qualification, and handover of manufacturing equipment, tooling, fixtures, and supporting infrastructure.Assist with execution of equipment qualification and validation activities, including:FAT & SAT supportIQ/OQ/PQ execution supportEquipment characterisation supportPerformance qualification study supportExecute approved protocols and record data accurately in accordance with GDP, GMP, and site quality system requirements.Support preparation, review, and closure of validation documentation, action items, and straightforward deviations.Escalate equipment, process, or documentation issues identified during installation, commissioning, qualification, and start-up.Work with Process Development, Equipment Engineering, Quality, Facilities, and Operations to support resolution of straightforward equipment or process issues.Manufacturing Line & Facility Start-UpAssist in the setup of manufacturing workstations, production areas, station layouts, room layouts, and utility requirements.Support mapping of material, product, waste, and personnel flows, including use of spaghetti diagrams where appropriate.Support implementation of 5S, visual workplace standards, and workplace organisation principles.Assist with identifying equipment, tooling, fixtures, tables, utilities, drops, cables, and other infrastructure requirements.Support line trials, commissioning activities, unit operation shakedown, run-rate readiness, and operational readiness exercises.Communicate line issues, concerns, and watch-outs to Manufacturing Engineering, Operations, and project team members.Process Documentation & SystemsSupport creation, update, and maintenance of appropriate manufacturing and engineering documentation, including:SOPsSGOIsStandard workProcess instructionsBatch documentationEquipment recordsValidation recordsTechnical reportsAssist with gathering information required for:MES process modellingElectronic batch record requirementsSAP material setupBOMsRoutersProcess plansCompile and organise technical information for review by Process Development, Quality, Operations, and project stakeholders.Ensure assigned documentation tasks are completed accurately and in compliance with GMP and site quality system requirements.Materials, Flow & Supply Chain IntegrationSupport mapping of raw materials, intermediates, consumables, waste streams, and finished product flow.Assist with defining material storage, staging, and movement requirements for the manufacturing process.Support setup of consumables used in the manufacturing process, including replenishment strategies and Kanban-style controls where applicable.Assist with documentation required for material masters, BOMs, approved vendors, consumable control, and material availability.Work with Warehouse, Planning, Procurement, Manufacturing, and Quality teams to support material readiness for start-up and sustained manufacturing.Support management of material risks where identified by the business, escalating issues appropriately.Quality, EHS & Risk ManagementFollow all Quality System, GMP, EHS, and site procedural requirements.Support risk management activities, including FMEA, HAZOP, SWIFT studies, EHS assessments, and process safety reviews.Assist with contamination control and micro-monitoring readiness activities where required.Support investigations into process, equipment, material flow, or documentation issues using defined procedures.Assist with implementation of corrective and preventive actions under guidance from more senior engineers or Quality team members.Support development and documentation of scrap, reconciliation, and waste handling processes.Process Monitoring & Continuous ImprovementSupport production line and process monitoring activities under guidance from Manufacturing Engineer II, Senior Engineers, or Operations.Collect, trend, and organise data relating to yield, scrap, downtime, equipment performance, process stability, and production readiness.Identify and escalate process problems, equipment issues, and opportunities for improvement.Support continuous improvement activities focused on quality, service, cost, productivity, yield, safety, and space utilisation.Assist in implementing approved process improvements and controls on the manufacturing floor.Apply root cause analysis to investigate process deviations and equipment issues.Training & Cross-Functional CollaborationSupport training activities for Product Builders, operators, technicians, and manufacturing personnel on new or revised processes.Assist with preparation of training materials and process knowledge transfer documentation.Participate in cross-functional project meetings and provide updates on assigned tasks.Work closely with Operations, Quality, Process Development, Sterilisation, R&D, Warehouse, Laboratory, Facilities, Planning, Procurement, and Equipment Engineering teams.Take direction from Manufacturing Engineer II, Senior Engineers, project leads, and management on priorities, technical approach, and execution of assigned activities.Build technical knowledge of hydrogel/polymer manufacturing processes, equipment, validation, documentation, and site systems through hands‑on project involvement.Process‑Specific Responsibilities (Hydrogel / Polymer Manufacturing)Support data collection and documentation for critical process parameters associated with hydrogel/polymer manufacturing, including:Temperature profilesReactant ratiosMixing conditionsCuring/polymerisationWashing and purificationTransfer stepsSupport scale‑up and process robustness activities, including:Polymerisation behaviour and curingResidual monomer controlMechanical properties (e.g., modulus, swelling behaviour)Process reproducibilitySupport compilation of process development, characterisation, and technical data for use in manufacturing documentation, validation readiness, and process control activities.Education & ExperienceHons Bachelor’s degree or higher in Engineering or a related technical discipline such as Chemical, Process, Mechanical, Manufacturing, Biomedical, Materials, or Polymer Engineering.1–3 years’ experience in process engineering, manufacturing engineering, equipment engineering, or a related technical role.Exposure to one or more of the following is desirable:GMP documentationEquipment qualification or validationManufacturing line supportProcess mappingData collection and analysisContinuous improvementMES, SAP, BOMs, routers, or electronic batch record systemsLean, 5S, or Six Sigma toolsCore CompetenciesStrong attention to detail and documentation discipline.Ability to follow defined procedures and elevate issues appropriately.Good analytical and problem‑solving skills.Strong data collection, organisation, and presentation abilities.Effective communication skills, including questioning and ensuring understanding.Teamwork in a cross‑functional project environment.Willingness to learn manufacturing, validation, quality, and hydrogel/polymer process fundamentals.Practical, hands‑on approach to supporting manufacturing process, equipment, and line development.This role will require travel for 30%+ of your time.Equality, Diversity & InclusionBoston Scientific is proud to be an equal opportunity and affirmative action employer. We are committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com.
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