Senior Process Development Engineer

Diversity - Innovation - 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… ## What you'll do - Lead process development activities for complex, highly automated manufacturing systems from concept and feasibility through design, build, integration, validation, production release and lifecycle support. - Develop and document the manufacturing process, including process characterisation, critical process parameters, operating windows, control strategies, acceptance criteria and production performance ## What you'll bring . - Translate product, process, quality, safety and operational needs into clear equipment and automation requirements for large capital projects. - Provide technical leadership for equipment architecture and integration across mechanical systems, controls, robotics, machine vision, sensors, motion, data connectivity and production interfaces. - Plan and execute feasibility studies, proof-of-concept work, engineering trials, development builds and structured process experiments to reduce technical risk before final equipment qualification. - Assess process capability and equipment performance using data-driven methods; identify sources of variation and implement robust corrective or improvement actions. - Lead or support design reviews, technical reviews, risk reviews, Factory Acceptance Testing, Site Acceptance Testing, installation, commissioning and production readiness activities. - Own or contribute to process and equipment risk management, including process FMEA, equipment FMEA, fault handling, error-proofing, inspection strategy and control plan development. - Define and execute validation strategies and author or review protocols and reports for equipment, software, vision systems and manufacturing processes in accordance with the Quality System. - Ensure complete, accurate and traceable technical documentation, including specifications, drawings, bills of materials, software documentation, test evidence, maintenance requirements, training materials and production procedures. - Partner with Quality, Operations, Product Development, Automation, Controls, Facilities, EHS, IT/OT, Validation, Maintenance and external equipment suppliers to deliver safe, compliant and maintainable solutions. - Manage technical interfaces with machine builders and technology suppliers, including technical clarification, deliverable reviews, issue resolution, change control and acceptance against agreed requirements. - Provide Design for Manufacturability and Design for Automation input to product and fixture designs, with emphasis on stable handling, inspection, assembly and test processes. - Support equipment ramp-up, yield improvement, cycle-time optimisation, reliability growth and transition of ownership to manufacturing and equipment support teams. - Mentor engineers and technicians, share automation and process-development best practices, and contribute to standardisation of equipment platforms, vision approaches and engineering methods. Education & Experience: - Hons bachelor’s degree (level 8) or higher in an engineering or related technical discipline. - Demonstrated experience developing manufacturing processes on automated equipment, rather than equipment operation or project coordination alone. - Experience delivering or technically leading large capital equipment projects involving custom automation, system integration or complex production technology. - Experience working within a regulated industry and applying formal quality-system, risk-management, documentation and validation requirements. - Working knowledge of process validation, equipment qualification, statistical analysis, capability assessment, root-cause analysis and structured problem solving. - Ability to interpret and challenge mechanical, electrical, controls, software, pneumatic, vision and equipment-layout documentation. …

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