Manufacturing Engineer

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Advancing possibilities for a brighter tomorrow

We are seeking a Manufacturing Engineer on a permanent basis to join our team.

Job Purpose:

To 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.

The role will support assigned engineering, validation, documentation, and manufacturing readiness activities under the guidance of Manufacturing Engineer II, Senior Engineers, project leads, and management.

Key Responsibilities:

Technology Transfer & Process Development

• Support 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 & Validation

• Support 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 support
  • IQ/OQ/PQ execution support
  • Equipment characterisation support
  • Performance qualification study support

• Execute 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-Up

• Assist 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 & Systems

• Support creation, update, and maintenance of appropriate manufacturing and engineering documentation, including:

• • SOPs
  • SGOIs
  • Standard work
  • Process instructions
  • Batch documentation
  • Equipment records
  • Validation records
  • Technical reports

• Assist with gathering information required for:

• • MES process modelling
  • Electronic batch record requirements
  • SAP material setup
  • BOMs
  • Routers
  • Process plans

• Compile and organise technical information for review by Process Developent, 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 Integration

• Support 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 Management

• Follow 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 Improvement

• Support 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 Collaboration

• Support 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 profiles
  • Reactant ratios
  • Mixing conditions
  • Curing/polymerisation
  • Washing and purification
  • Transfer steps
    • • Support scale-up and process robustness activities, including:
  • Polymerisation behaviour and curing
  • Residual monomer control
  • Mechanical properties (e.g. modulus, swelling behaviour)
  • Process reproducibility

• Support compilation of process development, characterisation, and technical data for use in manufacturing documentation, validation readiness, and process control activities.

Education & Experience:

• Hons bachelor’s degree or higher in Engineering or 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 documentation
  • Equipment qualification or validation
  • Manufacturing line support
  • Process mapping
  • Data collection and analysis
  • Continuous improvement
  • MES, SAP, BOMs, routers, or electronic batch record systems
  • Lean, 5S, or Six Sigma tools
  •  

• Strong attention to detail and documentation discipline.
• Ability to follow defined procedures and escalate issues appropriately.
• Good analytical and problem-solving skills for issues.
• Ability to collect, organise, and present data clearly.
• Good communication skills, including asking questions and checking understanding.
• Ability to work effectively 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.

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 isn’t just business, it’s personal. And if you’re 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!

To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.  Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email [email protected]