Principal Controls and Software Engineer

Shape the Future of Regenerative Medicine Manufacturing

At Xeltis, we are pioneering transformative medical technologies that enable the body's natural healing processes to create living and durable vascular implants. As we transition from technology development into clinical and commercial-scale manufacturing, we are looking for an experienced Principal Controls & Software Engineer.

The Role

As Principal Controls & Software Engineer, you will lead the architecture, development and implementation of our advanced control systems and embedded and software applications. You will bring strong knowledge of Computerised System Validation (CSV) and of software verification and validation (V&V).

This is a unique opportunity for an experienced Controls & Software Engineer to take ownership of ensuring that our manufacturing/ Shopfloor Control processes are scalable, compliant, reliable, and ready to support global commercialization. The scope also includes our business applications & data architecture such as; SCM, logistics and our azure (middleware) platform.

Working with our Business leaders across e.g., Supply Chain Management, Logistics, Engineering, Manufacturing, Quality, R&D and External partners, you will ensure that Xeltis' control systems business applications & data architecture, meet the highest standards of performance, regulatory compliance, and operational excellence.

Key Responsibilities

Advanced control systems and embedded/software applications;

• Lead the design and development of control algorithms and software architectures.

• Develop and maintain embedded software, real-time control systems, and automation applications.

• Define system requirements, specifications, and technical standards.

• Perform system modelling, simulation, testing, and validation.

• Integrate hardware, software, sensors, actuators, and communication protocols.

• Troubleshoot and resolve complex system and software issues.

• Conduct design reviews and ensure compliance with industry standards and safety regulations.

• Provide technical guidance and mentorship to engineering teams.

• Collaborate with product management, hardware engineers, manufacturing teams, and customers.

• Drive continuous improvement, innovation, and technology roadmaps.

• Support project planning, risk assessment, and resource estimation.

• Document designs, test procedures, and engineering solutions.

Automation Strategy & Architecture

• Define and govern the long-term automation and control systems roadmap across manufacturing operations.

• Develop scalable, modular, and standardised control system architectures across equipment and facilities.

• Drive harmonisation of software platforms, coding standards, and automation best practices.

• Ensure automation solutions support future product and manufacturing expansion.

• Serve as the Design Authority for automation, controls, software and manufacturing systems within Engineering & Manufacturing, approving architectural decisions and technical standards, and advising on enterprise technology selection together with IT and the relevant function owners.

Software Compliance (CSV) & Regulatory Leadership

• Act as the company's subject matter expert for GMP, GAMP, NIS2, software validation, data integrity, and electronic records compliance.

• Ensure control systems, manufacturing software, other business software meet medical device and regulatory requirements.

• Lead validation activities and support regulatory inspections and audits.

Manufacturing Scale-Up & Technology Transfer

• Lead the translation of laboratory and R&D processes into robust, automated manufacturing systems.

• Drive software automation strategies that improve process reproducibility, product consistency, and manufacturing efficiency.

• Support technology transfer activities from development to commercial production environments.

Digitalisation & Advanced Process Control

• Identify and implement advanced control strategies to optimise manufacturing performance.

• Drive integration of process analytical technologies (PAT), and our application architecture e.g., manufacturing execution systems (MES), and data management platforms.

• Champion digital transformation initiatives that enhance operational insight and process understanding.

• Develop the long-term Industry 4.0 roadmap covering cloud integration, advanced analytics and AI-enabled process optimisation.

Reliability & Operational Excellence

• Establish standards for automation system reliability, cybersecurity, maintenance, and lifecycle management.

• Define and govern OT cybersecurity architecture in accordance with IEC 62443 and corporate cybersecurity policies.

• Develop strategies to maximise equipment uptime and minimise operational risk.

• Lead root cause investigations and continuous improvement efforts relating to automation systems.

Technical Leadership & Mentoring

• Provide senior technical leadership across multidisciplinary engineering projects.

• Serve as the primary controls and software technical interface between Engineering, Manufacturing, Quality, and external vendors.

Vendor & Systems Integration Management

• Define automation specifications and standards for equipment suppliers and systems integrators.

• Ensure third-party systems integrate seamlessly with Xeltis infrastructure and long-term automation strategy.

• Oversee vendor performance throughout system design, implementation, and commissioning.

Essential Qualifications & Experience

• Master's degree or PhD in Automation Engineering, Control Systems Engineering, Software Engineering, Electrical Engineering, or a related discipline.

• Significant experience in industrial automation, control systems, and manufacturing software within regulated industries.

• Strong knowledge of Siemens PLC’s, Ignition SCADA, HMI, and industrial control system architectures, programming and debugging.

• Demonstrated experience leading automation projects from concept through commissioning and validation.

• Deep understanding of GMP, GAMP5, CSV and data integrity requirements.

• Experience supporting manufacturing scale-up, technology transfer, and process automation initiatives.

• Proven ability to establish technical standards and influence engineering strategy across organisations.

• Experience managing external automation vendors and systems integrators.

Technical Expertise

• Control system architecture and design, PLC code development, debugging and Troubleshooting.

• Industrial networking and cybersecurity

• Manufacturing data management and system integration

• Advanced process control methodologies

• MES, historian, and industrial data platforms

• Software validation and lifecycle management

• Regulatory compliance in medical device, pharmaceutical, biotech, or related industries

Soft Skills & Leadership Attributes

• Strategic thinker with the ability to balance long-term vision and practical execution.

• Strong leadership and influencing skills across all organisational levels.

• Excellent problem-solving and analytical capabilities.

• Strong communication skills, capable of translating complex technical concepts for diverse audiences.

• Highly organised with the ability to manage multiple priorities in a fast-paced environment.

• Passionate about innovation, continuous improvement, and engineering excellence.

Why Join Xeltis?

At Xeltis, you will have the opportunity to make a meaningful impact on a technology that has the potential to transform patient outcomes globally. You will work alongside world-class scientists, engineers, and manufacturing professionals in a collaborative and innovative environment where your expertise will directly influence the future of regenerative medical device manufacturing.

If you are excited by the challenge of building scalable, compliant, and cutting-edge manufacturing automation systems in a rapidly growing MedTech company, we would love to hear from you.

Xeltis is an equal opportunity employer. We welcome all qualified applicants and make employment decisions without regard to age, gender, ethnicity, nationality, religion, disability, sexual orientation, or any other characteristic protected by applicable law.

Apply now and help shape the future of regenerative medicine at Xeltis.