The posting
Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.
Summary of the role
As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.
Essential Job Duties and Responsibilities
· Assess complex system and software challenges, determine root cause, and define practical technical solutions that improve reliability, performance, availability, cybersecurity, serviceability, and manufacturability.
· Develop, review, and maintain system-level requirements, software requirements, architecture descriptions, interface definitions, control logic, design rationale, and related technical documentation.
· Partner with software, electrical, mechanical, manufacturing, quality, regulatory, service, and operations teams to define functional specifications and ensure software performs effectively as part of the overall product system.
· Create and maintain system architecture using sound engineering practices, design control principles, risk-based decision making, and applicable company procedures.
· Evaluate software interfaces, embedded control behavior, third-party device communication, user interface behavior, data handling, system alarms, and integration with electrical and mechanical subsystems.
· Support software development planning and execution by helping define scope, technical approach, sequencing, dependencies, deliverables, estimates, risks, and development priorities.
· Translate system needs into well-defined stories, acceptance criteria, and technical clarification that enable development teams to estimate, prioritize, implement, and verify work effectively.
· Draft and review software test plans, verification protocols, and test evidence to improve coverage, robustness, traceability, risk alignment, and traced to approved requirements.
· Analyze, review, and verify that system and software designs meet intended use, approved requirements, performance expectations, cybersecurity considerations, and applicable regulatory expectations.
· Collaborate on issue investigations, complaint support, field/service feedback, manufacturing concerns, defect resolution, corrective actions, and continuous improvement activities involving software-controlled products.
· Provide senior-level technical judgment for mission-critical systems, including recommendations that support high availability, maintainability, cybersecurity, product quality, and long-term platform sustainability.
· Prepare and review engineering change documentation, risk inputs, traceability records, verification summaries, design review materials, investigation summaries, and other quality system documentation.
· Ensure assigned work is completed in alignment with applicable quality system procedures, software lifecycle expectations, risk management practices, cybersecurity expectations, and regulated medical device requirements.
· Actively support continuous improvement of engineering processes, documentation quality, team capability, and product robustness by identifying opportunities and sharing lessons learned.
· Perform other duties as assigned.
Education and Experience Requirements
- Bachelor’s degree in Software Engineering, Computer Engineering, Computer Science, Systems Engineering, Electrical Engineering, or a related technical discipline required.
- Minimum of 8–10 years of progressive experience in software engineering, systems engineering, embedded systems, product development, or software-controlled electromechanical systems.
- Experience developing, documenting, or supporting software requirements, system architecture, software development plans, verification activities, and technical design documentation required.
- Experience working in regulated industries such as medical device, life sciences, aerospace, or automotive required.
- Medical device software lifecycle, design controls, risk management, cybersecurity, and software validation experience required.
- Demonstrated experience leading technical work independently while collaborating with cross-functional engineering, quality, regulatory, manufacturing, and service teams.
- Experience leading a team of junior software engineers to deliver fully implemented, reviewed, tested and documented software to meet requirements.
- Experience demonstrating project management skills for delivering Software projects from start to finish.
Required Skills and Abilities
- Strong system-level understanding of software-controlled products, embedded systems, electromechanical devices, and integrated hardware/software platforms.
- Demonstrated ability to define system architecture, software interfaces, requirements, control logic, algorithms, and integration strategies.
- Strong working knowledge of software development lifecycle practices in Medical devices, requirements management, design documentation, verification planning, defect resolution, and traceability.
- Ability to generate software test plans, test coverage, verification evidence, risk-based testing, and alignment between requirements and test cases.
- Experience writing advanced embedded software, device communication, third-party software interface, graphical user interface software, data handling, cybersecurity considerations, and system performance improvements.
- Strong analytical and troubleshooting skills with the ability to diagnose complex issues across software, firmware, electronics, sensors, mechanical subsystems, and manufacturing processes.
- Ability to lead technical projects, facilitate cross-functional problem solving, influence design direction, and drive actions to closure without direct supervision.
- Knowledge of regulated product development, quality system expectations, design controls, risk management, software documentation, and change control processes.
- Strong technical writing and communication skills, including requirements, architecture documentation, validation or verification reports, investigations, engineering changes, and leadership updates.
- Comfortable communicating complex software and system-level issues to technical and non-technical stakeholders.
Interested?
If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.
About Nordson Medical
At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.
