Manufacturing Engineer II

Job Purpose:

To 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 Responsibilities:

Technology Transfer & Process Development
Lead 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 & Validation
Support 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-Up
Support the 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 & Systems
Develop implement and maintain appropriate 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 Integration
Define 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 Management
Support 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 Improvement
Monitor 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 Collaboration
Train 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 & Experience:

• Hons bachelors degree or higher in engineering or related technical discipline such as Chemical Process Mechanical Manufacturing Biomedical Materials or Polymer Engineering.
• 25 years experience in process engineering manufacturing engineering equipment engineering or a related technical role.
• Experience in a regulated manufacturing environment such as 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/PQ
  • FAT and SAT execution
  • Process validation or process characterisation
  • GMP documentation
  • Manufacturing line start-up
  • Product or process transfer
  • MES SAP BOMs routers or electronic batch record systems
  • Lean 5S continuous improvement or Six Sigma tools

• Strong 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% of your time.

As a leader in medical science for more than 40 years we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives create value for our customers and support our employees and the communities in which we operate. Now more than ever we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So choosing a career with Boston Scientific isnt just business its personal. And if youre a natural problem-solver with the imagination determination and spirit to make a meaningful difference to people worldwide we encourage you to apply and look forward to connecting with you!

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