Senior Manufacturing System Engineer

About the role

Stryker is looking for a curious, hands-on Senior Manufacturing System Engineer in Belfast. The role involves developing, implementing, validating and continuously improving digital systems that support medical device manufacturing, working across Manufacturing, Quality, Regulatory Affairs, IT, Supply Chain and Engineering functions. Work is onsite.

Key responsibilities

• Act as System Owner for assigned manufacturing applications such as ERP, MES, labelling and manufacturing databases, reporting platforms and license management systems.
• Keep assigned systems compliant, validated, secure and fit for use through lifecycle management, including implementation, change control, validation, periodic review, user access management and continuous improvement.
• Develop and maintain manufacturing software, electronic records, reporting tools and digital workflows in line with GMP, FDA, ISO 13485 and 21 CFR Part 11.
• Lead Computer System Validation (CSV) activities, including validation plans, risk assessments, URS, IQ/OQ/PQ protocols, traceability matrices and validation summary reports.
• Support SAP Business One processes such as bill of materials, production orders, material management, inventory control, warehouse management, serial/batch traceability and engineering changes.
• Build SQL queries, SAP queries, dashboards and reporting solutions, and partner with Operations, Quality, Regulatory Affairs, Supply Chain, IT and external vendors to deliver validated systems.
• Monitor system performance and data integrity, support business continuity planning and ensure backup, recovery and contingency processes for critical systems.

Required profile

• Level 6 degree in Science, Engineering or a related technical discipline.
• 2-4 years' experience in a manufacturing environment.
• Proven project management skills and leadership ability to negotiate and influence others.
• Ability to work autonomously and in a multi-disciplined, fast-paced team.
• Good knowledge of GMP/FDA requirements and Health and Safety regulations.

Required skills

• SAP Business One or other ERP experience preferred.
• Basic SQL and database query creation.
• Power BI, Power Apps and Power Automate desired.

What we offer

• Salary range of GBP 36,800 - 61,200 per year, with possible incentive compensation.
• Comprehensive benefits package.
• 10% travel percentage.