Medical Device Development Lead
2 days ago
San Sebastián
Position: Medical Device Development Lead Level: Mid - Senior Type : Internal, Full-time Location: Spain (work permit provided for non-EU employees, must be willing to relocate) Job description : This is a full-time role for a Medical Device Development Lead with flexible location based in 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. The Medical Device Development Lead will own and contribute to comprehensive design initiatives across the full product life cycle. Main Responsibilities: Drive device development projects across all design stages, collaborating with subject matter experts to complete deliverables following applicable Design Controls. Author key Design History File documents (DIR, Design V&V reports, etc.) and complete phase reviews. Draft applicable Risk Management and Human Factors documentation, improving product design and user interactions (RM Plan, FMEA, URRA, Task/Comparative Analysis, etc.). Ensure that medical device RM and Usability considerations are documented according to applicable standards (e.g., ISO 14971, IEC 62366). Collaborate with manufacturers as technical lead, planning assemblies required for testing, clinical trial, or commercial production. Support Post-Market Surveillance activities and determine necessary updates to product design, Risk File, and Usability based on collected feedback. Support Regulatory Affairs in preparing medical device pre-registration documents (various regions). Provide input to health authority inquiries. Work with common word processing, spreadsheet, and collaborative tools (e.g., Microsoft Office), and present online in video conferences. Candidate profile and required qualifications: Relevant Experience: a minimum of 5 years within the medical device or pharmaceutical industry is required (e.g., developing medical devices, SaMD, combination products, IVDs). Studies: BS, MS, or PhD. in Engineering or health-related field. Experience working with cross-functional teams in medical device development from concept to market launch. Prior experience as a subject matter expert responsible for DHF documentation (e.g. R&D, RM, HFE, QA, RA, Clinical). 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. Familiarity with global regulatory requirements (FDA, CE Marking, ISO 13485, MDR, etc.). Experience with HA submission preparation is a plus. Interested in gaining experience in multiple key roles of medical device development, across various technologies. Experience in medical device software development or connected SW/HW is a plus. Language Requirement: English – Full proficiency reading/writing. If applicable, willing to relocate - flexible location residing in Austria or Spain. What we offer: One of the best overall career opportunities in the sector Rapid learning and development opportunities on a global scale Very competitive salary/bonus 5 weeks vacation + local holidays Optimal work-life balance with a company policy and management approach built 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 Fun fact: we come from 7 different countries and 4 continents 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.
