ppbPosition: /b Human Factors Usability Engineer – Medical Devices /ppbLevel: /b Mid-level to Senior /ppbType /b : Internal, Full-time /ppbLocation /b : Austria or Spain (work permit provided for non-EU employees, bmust /b be willing to relocate) /ppbJob description /b : This is a full-time role for a Human Factors Engineer with flexible location based in Austria or Spain. The position will offer the opportunity to work with a global cross‑functional team, supporting medical device design stage initiatives while gaining exposure to various technologies. The role will involve in‑person and/or remote collaboration as needed according to assigned projects. /ppThe Human Factors Usability Engineer will own and contribute to comprehensive design initiatives across the full product life cycle. /ppbMain Responsibilities: /b /pulliServe as the Human Factors SME for development projects across all design stages, working closely with cross‑functional teams, while ensuring HFE inputs are accurately documented as DHF deliverables. /liliLead the definition and implementation of HFE strategy tailored to the product, intended use, patient population, use environment and risk profile. /liliOwn the creation and maintenance of HFE documentation, including HF Plans, Application Specifications, Task Analyses, URRAs, User Study Plan/Reports, Expert Reviews and Comparative Analyses, ensuring completeness and alignment with project goals. /liliPromote the development of safe and user‑centric medical devices by proposing mitigations and design recommendations based on literature reviews, known use problem searches, comparable devices, observed task behavior and user feedback. /liliEnsure all HFE activities align with applicable standards and guidance (e.g., ISO 14971, IEC 62366) and are integrated with risk management processes.



/liliPlan and execute formative and summative user studies throughout the development cycle, assessing and summarizing results in validation reports. /liliManage and coordinate external HFE vendors, including usability testing labs and consulting partners, to ensure effective execution of human factors activities and timely delivery of outputs. /liliSupport Regulatory Affairs in drafting US FDA 510(k) submissions and EU Technical Documentation for CE marking. Provide HFE expertise during audits, inspections, and Health Authority reviews to address deficiencies or additional information requests. /liliSupport product commercial phases, including conducting HFE assessments for product changes and post‑market activities to ensure continued usability and safety. /liliWork with common word processing, spreadsheet, and collaborative tools (e.g., Microsoft Office), and communicate effectively through presentations and online/in‑person meetings. /li /ulpbCandidate profile and required qualifications: /b /pulliRequired Experience: a minimum of 5 years applicable experience in Human Factors / Usability Engineering (8 years for Senior level) within the medical device or pharmaceutical industry (e.g., developing SaMD, combination products, IVDs, etc.). /liliStudies: BS, MS, or PhD. in Behavioral Sciences, Engineering, Industrial Design, or other field relevant to life sciences and Human Factors.



/liliExperience working with cross‑functional teams in medical device development from concept to market launch. /liliStrong knowledge of applicable regulations and standards (e.g., ISO 14971, IEC 62366, FDA HFE guidance). /liliExperience planning and conducting usability studies and summarizing findings in regulatory documentation. /liliSelf‑directed, works independently in a remote setting and as part of a team. /liliDemonstrates excellent interpersonal skills, working with diverse groups of people in a general arena. /liliAbility to drive decisions, promote progress, and manage multiple projects. /liliOffers strategic and practical solutions to development team, presenting findings in concise and clear manner. /liliInterested in gaining experience in multiple key roles of medical device development, across various technologies. /liliLanguage Requirements: bEnglish /b – Full proficiency reading/writing. /liliIf applicable, willing to relocate - flexible location residing in bAustria or Spain /b. /li /ulpbWhat we offer /b /pulliOne of the best overall career opportunities in the industry. /liliAccelerated professional development while working with global industry leaders. /liliVery competitive salary/bonus. /lili5 weeks of vacation + local holidays. /liliOptimal work‑life balance with a company policy and management approach designed for sustainable career satisfaction. /liliHealth insurance and a culture geared toward health and well‑being. /liliAn amazing collaborative team that is diverse, talented, and ready to celebrate success. /li /ulpSuma Medtec GmbH is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We encourage applications from candidates of all backgrounds, experiences, and perspectives. /p /p #J-18808-Ljbffr

📌 Human Factors & Usability Engineer – Medical Devices (Barcelona)
🏢 Suma Medtec
📍 Barcelona