Human Factors Engineer – Medical Devices
hace 5 días
Barcelona
Position: Human Factors & Usability Engineer – Medical Devices Level: Mid-level to Senior Type: Internal, Full-time Location: Austria, Spain, or Germany (work permit provided for non-EU employees, must be willing to relocate) Job description: This is a full-time role for a Human Factors Engineer with flexible location based in Austria, Spain, or Germany. 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. The Human Factors & Usability Engineer will own and contribute to comprehensive design initiatives across the full product life cycle. Main Responsibilities: • Serve 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 in DHF deliverables., • Lead the definition and implementation of HFE strategy tailored to the product, intended use, user/patient population, use environment and risk profile., • Own the creation and maintenance of HFE documentation, including HF Plans, Application Specifications, Task Analyses, URRAs, User Study Plan/Reports, Expert Reviews, Comparative Analyses, ensuring completeness and alignment with project goals., • Promote 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., • Ensure all HFE activities align with applicable standards and guidance (e.g., ISO 14971, IEC 62366) and are integrated with risk management processes., • Plan and execute formative and summative user studies throughout the development cycle, assessing and summarizing results in validation reports., • Manage 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., • Support 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., • Support product commercial phases, including conducting HFE assessments for product changes and post-market activities to ensure continued usability and safety., • Work effectively with common word processing, spreadsheet, and collaborative tools (e.g., Microsoft Office), and communicate findings clearly through presentations and online/in-person meetings. Candidate profile and required qualifications: • Required 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.)., • Studies: BS, MS, or PhD. in Engineering, Industrial Design, Psychology, or other field relevant to life sciences and Human Factors., • Experience working with cross-functional teams in medical device development from concept to market launch., • Strong knowledge of applicable regulations and standards (e.g., ISO 14971, IEC 62366, FDA HFE guidance)., • Experience planning and conducting usability studies and summarizing findings in regulatory documentation., • Self-directed, works independently in a remote setting and as part of a team., • Demonstrates excellent interpersonal skills, working with diverse groups of people in a global arena., • Ability to drive decisions, promote progress, and manage multiple projects., • Offers strategic and practical solutions to development team, presenting findings in concise and clear manner., • Interested in gaining experience in multiple key roles of medical device development, across various technologies., • Language Requirements: English – Full proficiency reading/writing., • If applicable, willing to relocate - flexible location residing in Austria, Spain, or Germany. What we offer • One of the best overall career opportunities in the sector, • Accelerated development opportunities while working with global industry leaders, • Very competitive salary/bonus, • 5 weeks of vacation + local holidays, • Optimal work-life balance with a company policy and management approach designed for sustainable career satisfaction, • Health insurance and a culture geared toward health and well-being, • An amazing collaborative team that is diverse, talented, and ready to celebrate success About our company: Suma Medtec accelerates development projects for medical device and pharmaceutical manufacturers of all sizes. We support all aspects of product development and commercialization, with specialized competencies in Global Regulatory Affairs, Risk Management, Human Factors, Project Management, R&D Engineering, and Quality. For additional information about Suma Medtec, we invite you to visit our website: Suma 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. Please note that applications received through third-party staffing or recruiting companies will not be considered.
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