Manufacturing engineer ii

Job PurposeTo engineer, implement and support highly capable and effective manufacturing processes for a hydrogel-based medical device product, contributing to successful process transfer, facility start-up, and sustained commercial manufacturing. The role will support the transfer of manufacturing capability from an external site into the receiving facility, with responsibility for assigned technical workstreams across process development, equipment qualification, manufacturing readiness, documentation, and continuous improvement.Key ResponsibilitiesTechnology Transfer & Process DevelopmentLead and support technology transfer of hydrogel/polymer-based manufacturing processes into the site.Translate process knowledge into scalable, repeatable, and GMP‑compliant manufacturing processes.Support definition of process flow from bulk solution through to finished product, including material handling, intermediate processing steps, waste streams, and reconciliation points.Support process characterization, process capability assessment, and design for manufacturability activities.Participate in detailed project planning and execution for product/process transfer, facility start‑up, and production readiness activities.Support development of manufacturing control strategies based on process knowledge, technical data, and quality system requirements.Equipment Engineering & ValidationSupport specification, procurement, installation, commissioning, qualification, and handover of manufacturing equipment, tooling, fixtures, and supporting infrastructure.Lead/support assigned equipment qualification activities, including FAT and SAT; IQ/OQ execution; PQ support; equipment characterization; performance qualification studies.Develop and execute validation protocols and reports applicable to new or transferred processes in accordance with site quality system requirements.Support resolution of equipment and process issues identified during installation, commissioning, qualification, and start‑up.Ensure compliance with site Equipment and Automated Systems procedures, GMP requirements, and applicable validation standards.Manufacturing Line & Facility Start‑UpSupport development and implementation of manufacturing line layouts, station layouts, room layouts, and utility requirements.Support material, product, waste, and personnel flow mapping, including use of spaghetti diagrams where appropriate.Support implementation of 5S, visual workplace standards, and workplace organization principles.Work with Facilities, Equipment Engineering, Manufacturing, and project teams to support equipment placement, services, drops, cabling, and other infrastructure requirements.Lead/support assigned line commissioning, unit operation shakedown, run‑rate readiness, and operational readiness activities.Support transition of new or transferred processes into routine manufacturing.Process Documentation & SystemsDevelop, implement, and maintain supporting documentation, including SOPs, SGOIs, standard work, process instructions, validation documentation, technical reports, process plans, BOMs and routers.Support implementation of manufacturing systems, including MES process modelling, electronic batch record requirements, SAP material setup, BOMs and process flows.Ensure documentation is accurate, controlled, and compliant with GMP and site quality system requirements.Compile and organise technical data to support reviews, decisions, and cross‑functional project discussions.Materials, Flow & Supply Chain IntegrationDefine and implement material flow, storage strategies, consumable management, and waste stream mapping in collaboration with Warehouse, Planning, Procurement, Quality, and Operations.Support setup of consumables used in the manufacturing process, including replenishment strategies, Kanban‑style controls, and material availability processes.Support vendor setup, approved vendor list activities, and material control requirements as needed.Work cross‑functionally with Warehouse, Planning, Procurement, Manufacturing, and Quality to ensure material readiness for start‑up and sustained manufacturing.Support identification and control of material risks on the production floor in cooperation with Quality, Supplier Quality, Manufacturing, and support functions.Quality, EHS & Risk ManagementSupport risk management activities, including FMEA, HAZOP, SWIFT studies, EHS assessments, and process safety reviews.Support Environmental Health & Safety compliance activities associated with new equipment, processes, materials, and production layouts.Support contamination control and micro‑monitoring readiness activities where required, including identification of critical process areas and sampling considerations.Ensure adherence to Quality Policy, GMP, regulatory requirements, and all applicable site procedures.Support development and implementation of scrap, reconciliation, and waste handling processes, including appropriate coding, ownership, documentation, and escalation pathways.Process Monitoring & Continuous ImprovementMonitor process and equipment performance to support ongoing qualification, process stability, and manufacturing readiness.Compile and analyse data relating to yield, scrap, downtime, equipment performance, process capability, and production readiness.Use root cause analysis techniques to investigate process deviations, equipment issues, documentation issues, and material flow problems.Support implementation of robust corrective and preventive actions.Lead or contribute to technical improvements under the site continuous improvement programme, with focus on quality, yield, efficiency, cost, safety and space utilisation.Support ongoing process optimisation following facility start‑up and transfer into routine manufacturing.Training & Cross‑Functional CollaborationTrain and/or provide work direction to technicians, Product Builders, Manufacturing Engineer I team members, and manufacturing personnel as required as part of validation, start‑up, or process implementation activities.Support development of training materials and process knowledge transfer for new or transferred manufacturing processes.Act as an equipment and/or process subject matter contributor within assigned areas of responsibility.Liaise cross‑functionally with Manufacturing, Quality, Process Development, Sterilisation, R&D, Warehouse, Laboratory, Facilities, Planning, Procurement and Equipment Engineering teams in pursuit of project and business objectives.Provide technical guidance and support to cross‑functional teams on assigned process, equipment, and manufacturing readiness activities.Process‑Specific Responsibilities (Hydrogel / Polymer Manufacturing)Support definition and control of critical process parameters associated with hydrogel/polymer manufacturing, including temperature profiles, reactant ratios, mixing conditions, curing/polymerisation, washing and purification, transfer steps.Support scale‑up and process robustness activities related to polymerisation behaviour and curing; residual monomer control; mechanical properties (e.g., modulus, swelling behaviour); process reproducibility.Use process development, characterisation, and technical data to support manufacturing control strategy, process documentation, and validation readiness.Education & ExperienceHons bachelor’s degree or higher in engineering or related technical discipline such as Chemical, Process, Mechanical, Manufacturing, Biomedical, Materials, or Polymer Engineering.2–5+ years’ experience in process engineering, manufacturing engineering, equipment engineering, or a related technical role.Experience in a regulated manufacturing environment (medical device, pharmaceutical, biotechnology, chemical, or similar industry) is desirable.Experience with one or more of the following is desirable:Equipment qualification and validation, including IQ/OQ/PQFAT and SAT executionProcess validation or process characterisationGMP documentationManufacturing line start‑upProduct or process transferMES, SAP, BOMs, routers, or electronic batch record systemsLean, 5S, continuous improvement, or Six Sigma toolsCore CompetenciesStrong technical and analytical problem‑solving capability.Ability to work effectively in a cross‑functional, project‑based, and start‑up environment.Strong documentation discipline and attention to detail.Ability to organise, present, and explain technical data to internal stakeholders.Ability to manage multiple priorities and deliver assigned project milestones under general direction.Strong communication and teamwork skills.Practical, hands‑on approach to manufacturing process, equipment, and line development.This role will require travel for 30% or more of your time.Boston Scientific is an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. If you require a reasonable accommodation during the recruitment process, please email TalentAcquisitionIre@bsci.com.
#J-18808-Ljbffr