Hiring.Camp

Senior Process Development Engineer

Boston Scientific

·

Today

Location
Cork, CO,IE, IE
Type
Full-time
Department
Engineering
Seniority
Senior
Education
Bachelor
Source
Eightfold

Description

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 requirements. 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. 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. Experience working directly with automation suppliers or machine builders through specification, design, build, acceptance, installation and ramp-up. Strong technical communication, cross-functional leadership, planning and issue-resolution skills, with the judgement to make sound decisions in complex projects. Candidates should bring depth in at least one automation discipline and the ability to work effectively across the wider equipment system: Machine vision, particularly Cognex vision systems, including application development, lighting and optics selection, inspection strategy, fixturing, calibration, validation and production support. Industrial controls and software, including PLC-based control, HMI development, motion control, safety controls, equipment communications and structured fault or alarm handling. Robotics and automated material handling, including robot application design, end-of-arm tooling, guarding, safety integration and cycle-time optimisation. Mechanical design and mechanism development for precision assembly, handling, inspection, test, dispensing or packaging processes. Automation architecture and system integration across equipment modules, peripheral devices, data systems, networks and manufacturing interfaces. Medical-device manufacturing experience, particularly where automated equipment directly influences product quality, inspection, traceability or validated process performance.

Skills

Risk ManagementPLC

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