Senior Manufacturing System Engineer

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 ISOCFR 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: 36800 - 61200 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 addition to base salary this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable) along with Strykers comprehensive benefits package.

If youd 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.