Senior Process Development Engineer

Boston Scientific; Cork; On-site; EUR 70,000 - 100,000; Full time

Job summary

Boston Scientific is seeking a Senior Process Development Engineer to lead development, integration and validation of highly automated manufacturing systems in a regulated medical-device environment. You will drive process capability, transfer to production, and manage design reviews and FAT/SAT activities.

The role requires hands-on development across machine vision, controls, robotics and mechanical design, with leadership across large capital projects and partner collaboration with Quality

Qualifications

• Honors bachelor’s degree in engineering or related technical discipline.
• Experience delivering manufacturing processes on automated equipment in regulated environments.
• Strong knowledge of validation, equipment qualification, process capability and problem solving.

Responsibilities

• Lead process development for highly automated manufacturing systems from concept to production readiness.
• Define and document manufacturing processes, CPs, control strategies, and acceptance criteria.
• Provide technical leadership for equipment architecture across mechanical, controls, robotics, and vision.
• Mentor engineers and technicians and drive standardisation of platforms and methods.

Skills

Automation

Machine vision

Controls

Robotics

Cognex vision

Education

Engineering degree

Tools

PLC programming

HMI development

Robot integration

Job description

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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 tomorrowWe are seeking a Senior Process Development Engineer on a permanent basis to join our team.Job Purpose:Leads the process development, technical definition, integration and commercialization of complex automated manufacturing equipment for new products, capacity expansion and strategic manufacturing programmes. The role provides deep engineering leadership across large capital equipment projects, ensuring robust process capability, compliant validation and effective transfer into production in a regulated environment.Role Emphasis:Hands-on process development on automated equipment, supported by specialist capability in one or more of machine vision, controls, robotics, mechanical design, motion systems or equipment integration. Cognex vision experience is strongly preferred.Key Responsibilities: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.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.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.Preferred Technical BackgroundCandidates 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.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/careersAt 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 [e-mail]