We are looking for a curious, hands-on engineer who enjoys solving complex business and manufacturing systems challenges and transforming ideas into validated, compliant solutions. You are comfortable working across Manufacturing, Quality, Regulatory Affairs, IT, Supply Chain, and Engineering functions to develop, implement, validate, and continuously improve digital systems that support medical device manufacturing.
Key Areas of Responsibility:
· Act as System Owner for assigned manufacturing applications including ERP, MES, labelling databases, manufacturing databases, reporting platforms, license management and other computerized systems supporting manufacturing operations.
· Ensure assigned systems remain compliant, validated, secure and fit for intended use through effective lifecycle management including implementation, change control, validation, periodic review, user access management and continuous improvement.
· Develop, maintain and improve manufacturing software systems, electronic records, reporting tools and digital workflows in compliance with GMP, FDA, ISO 13485, 21 CFR Part 11 and applicable regulatory requirements.
· Lead Computer System Validation (CSV) activities, including the development and execution of Validation Plans, Risk Assessments, User Requirement Specifications (URS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
· Support SAP Business One processes including Bill of Material (BoM) management, Production Orders, Material Management, Inventory Control, Warehouse Management, Serial/Batch Traceability and Engineering Change implementation.
· Develop and maintain SQL queries, SAP Business One queries, dashboards and reporting solutions to support operational decision making, performance monitoring and data integrity.
· Partner with Operation, Quality, Regulatory Affairs, Supply Chain, IT and external vendors to deliver validated systems, ensuring robust integration, compatibility, and continuous improvement of manufacturing processes.
· Monitor system performance, data integrity and user requirements, proactively identifying and implementing improvements that enhance compliance, efficiency and business effectiveness.
· Support business continuity planning and ensure appropriate backup, recovery, and contingency processes are in place for critical manufacturing systems.
Qualifications, Knowledge and Skills
• Level 6 Degree in Science, Engineering or a related technical discipline is required.
• SAP Business One or other ERP system experience within a manufacturing environment is preferred.
• Basic SQL knowledge and ability to create database queries.
• Knowledge and experience with Power Bi, Power Apps, Power Automate is desired.
• Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
• Proven Project Management skills through the delivery of business-critical projects.
• Has 2-4 years’ experience in a manufacturing environment.
• Technological pioneer, willing to source, investigate and implement technological and automation advances
• Strong communication and influencing skills with both internal and external agents.
• Confident and effective decision maker, with a proven leadership ability to negotiate and influence others.
• Capable of working as part of a multi-disciplined team in an aggressive, dynamic and results motivated environment
• Demonstrable analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment
• Excellent presentation and written / verbal communication skills
• Demonstrable ability to work autonomously
• A team player, with a flexible approach.
United Kingdom Pay Ranges:
- United Kingdom: £36,800 - £61,200 GBP Annual
At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.
If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.
Travel Percentage: 10%
