QUALIFICATIONS AND EXPERIENCE:

Required:

• Bachelor’s degree in Engineering, Human Factors, Biomedical Engineering, or related field.
• 3+ years of experience in a regulated industry (preferably medical devices or pharmaceuticals), with exposure to systems engineering or product development processes.
• Familiarity with labelling standards and regulatory requirements in key markets (e.g., US, EU, APAC).
• Strong analytical and problem-solving skills, with an attention to detail.
• Effective communication and documentation skills.

Preferred:

• Experience in Human Factors Engineering or usability studies.
• Exposure to Model-Based Systems Engineering (MBSE) or requirement management tools (e.g., DOORS, Jama).
• Familiarity with digital labelling systems, eIFU platforms, or label lifecycle management tools.

LET’S TALK ABOUT THE ROLE:

We are seeking a highly motivated Labelling Systems Engineer to join our team, playing a key role in the design, development, verification, and lifecycle management of labelling systems for our medical devices. You will work cross-functionally with design, regulatory, quality, technical writing and manufacturing teams to ensure that product labelling—including instructions for use, packaging artwork, and device markings—meets user needs, regulatory requirements, and internal standards across global markets.

KEY RESPONSIBILITIES:

• Define and manage requirements for labelling systems, including usability, regulatory compliance, localization, and compatibility with product packaging and devices.
• Develop and maintain labelling system architectures and interfaces in collaboration with hardware, software, and regulatory teams.
• Lead risk assessments and usability evaluations related to labelling, including supporting Human Factors Engineering activities.
• Coordinate and contribute to labelling-related verification and validation (V&V) activities.
• Ensure labelling content and design comply with relevant standards (e.g., ISO 15223, IEC 82079, EU MDR, FDA 21 CFR Part 801).
• Support the change management process for labelling updates across multiple product lines and geographies.
• Contribute to continuous improvement of labelling processes, tools, and templates to improve efficiency and reduce risk.
• Collaborate with cross-functional teams to address field feedback or regulatory findings related to labelling.
• Support regulatory submissions by providing documentation, rationale, and risk assessments as required.