IoT Software Engineer - Smart Hub

SteelcoBelimed; Riese Pio X; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

International environment

Benefits and welfare initiatives

Open-minded team

Job summary

SteelcoBelimed in Italy seeks a software engineer to design, develop, maintain and test software for OS-based targets and embedded devices. You will work with R&D, Validation, Service and Product Management to ensure functionality, quality and regulatory compliance.

The role requires a minimum of 5 years in a manufacturing environment, strong regulatory knowledge (IEC 62304, ISO 13485, MDR familiarity), and excellent English. An ITS/university background is expected.

Qualifications

• Minimum 5 years in a similar role, preferably in manufacturing environments.
• Strong knowledge of medical device software lifecycles and applicable regulations.
• Experience with IEC 62304, ISO 13485, ISO 14971 or MDR a plus.

Responsibilities

• Design, develop, and maintain software for operation system-based target systems and embedded devices.
• Perform verification, validation, and automated testing in collaboration with stakeholders.
• Maintain software documentation in English and ensure regulatory compliance.
• Support software maintenance and continuous improvement activities.
• Collaborate with Service Department for on-site support as needed.

Skills

Software development

English proficiency

Regulatory knowledge

Team collaboration

Education

Technical high school diploma / ITS / university degree

Job description

Steelco and Belimed have joined forces to lead the way in advanced cleaning and sterile workflow solutions. This partnership is powered by our united strengths: a dynamic product range, relentless innovation, utmost reliability, and an unmatched commitment to customer satisfaction. As SteelcoBelimed, we “Innovate with confidence”, as we set new industry standards to meet our customer’s needs offering high-quality products and comprehensive services for Infection Control and Life Science.

Your Role

Design, develop, maintain and test software applications on operation system-based target systems and embedded systems intended to interface with devices and other applications, by carrying out activities in collaboration with multidisciplinary teams (R&D, Laboratory, Validation, Service, Product Management) in order to ensure the functionality, quality, maintainability and regulatory compliance of the software developed.

Tasks & Responsibilities

• Design, develop, and maintain software applications based on project requirements, ensuring quality, integration, and maintainability.
• Analyse project needs, identify suitable technologies and solutions, and share technical knowledge within the team.
• Define, develop, execute, and maintain verification and validation tests, including automated test environments, in collaboration with relevant stakeholders
• Perform manual end-to-end software testing on machines and systems.
• Manage software versioning, releases, updates, and related documentation through lifecycle management systems.
• Maintain software development documentation in English in compliance with company procedures and guidelines.
• Perform software maintenance and continuous improvement activities.
• Investigate and resolve software issues, collaborating with internal departments as needed.
• Support technical assistance activities in cooperation with the Service Department, including occasional customer site interventions.

Your Profile

Skills & Competencies

Technical skills:

• Software development, programming languages, databases, testing, networking, application development, APIs, and version control systems.
• Basic knowledge of electronics and electrical engineering.

Regulatory skills:

• Knowledge of medical device software lifecycle processes and applicable medical device regulations standard (IEC 62304, ISO 13485, ISO 14971, EN 62304, MDR, 21 CFR 820, and similar).
• Familiarity with pharmaceutical industry regulations and standards (EU GMP, FDA GMP, GAMP 5) will be considered a plus.
• Familiarity with IEC 61131 Software Language and IEC 62366 Usability requirements.

Other skills:

• Good English proficiency.
• Teamwork, proactive attitude, innovation mindset, and strong problem-solving skills.

Required Experience

At least 5 years in a similar role, preferably in manufacturing environments.

Required Education

Technical education background, acquired through a technical high school diploma, ITS qualification, or university degree.

Our Offer

• Work in an international, fast-growing industry that makes a real impact on healthcare and pharmaceutical industry.
• Be part of an innovative and open-minded team.
• Join a company with a strong reputation and long-standing expertise in cleaning and
• disinfection solutions.
• We offer a people-focused work environment, with dedicated benefits and welfare initiatives.