Manufacturing Engineer

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

At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll 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 bachelors degree or higher in Engineering or related technical discipline such as Chemical Process Mechanical Manufacturing Biomedical Materials or Polymer Engineering.
• 13 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 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!

To search and apply for open positions visit: 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