ph3Position: /h3 /brpMedical Device Development Lead /p /brh3Level: /h3 /brpMid - Senior /p /brh3Type: /h3 /brpInternal, Full-time /p /brh3Location: /h3 /brpAustria or Spain (work permit provided for non-EU employees, bmust /b be willing to relocate) /p /brh3Job description: /h3 /brpThis is a full-time role for a Medical Device Development Lead 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. /p /brpThe Medical Device Development Lead will own and contribute to comprehensive design initiatives across the full product life cycle. /p /brh3Main Responsibilities: /h3 /brul /brliDrive device development projects across all design stages, collaborating with subject matter experts to complete deliverables following applicable Design Controls. /li /brliAuthor key Design History File documents (DIR, Design VV reports, etc.) and complete phase reviews. /li /brliDraft or collaborate on applicable Risk Management and Human Factors documentation, improving product design and user interactions (RM Plan, FMEA, URRA, Task/Comparative Analysis, etc.). /li /brliEnsure that medical device RM and Usability considerations are documented according to applicable standards (e.g., ISO 14971, IEC 62366). /li /brliCollaborate with manufacturers as technical lead, planning assemblies required for testing, clinical trial, or commercial production. /li /brliSupport Post-Market Surveillance activities and determine necessary updates to product design, Risk File, and Usability based on collected feedback. /li /brliSupport Regulatory Affairs in preparing medical device submissions (e.g., US FDA 510(k),



EU Technical Documentation for CE marking, etc.). Support during audits, inspections, and Health Authority reviews to address deficiencies or additional information requests. /li /brliWork with common word processing, spreadsheet, and collaborative tools (e.g., Microsoft Office), and communicate effectively through presentations and online/in‑person meetings. /li /br /ul /brh3Candidate profile and required qualifications: /h3 /brul /brliRelevant Experience: a minimum of 5 years (8 years for Senior level) within the medical device or pharmaceutical industry is required (e.g., developing medical devices, SaMD, combination products, IVDs). /li /brliStudies: BS, MS, or PhD. in Engineering or health-related field. /li /brliExperience 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. RD, RM, HFE, QA, RA, Clinical). /li /brliSelf‑directed, works independently in a remote setting and as part of a team. /li /brliDemonstrates excellent interpersonal skills, working with diverse groups of people in a global arena. /li /brliAbility to drive decisions, promote progress, and manage multiple projects. /li /brliOffers strategic and practical solutions to development team, presenting findings in concise and clear manner. /li /brliFamiliarity with general regulatory requirements (FDA, CE Marking, ISO 13485, MDR, etc.). Experience with HA submission preparation is a plus.



/li /brliInterested in gaining experience in multiple key roles of medical device development, across various technologies. /li /brliExperience in SaMD, combination products, or IVD development is a plus. /li /brliLanguage Requirement: bEnglish /b – Full proficiency reading/writing. /li /brliIf applicable, willing to relocate - flexible location residing in bAustria /b orb Spain. /b /li /br /ul /brh3What we offer /h3 /brul /brliOne of the best overall career opportunities in the industry /li /brliAccelerated professional development while working with global industry leaders /li /brliVery competitive salary/bonus /li /brli5 weeks vacation + local holidays /li /brliOptimal work‑life balance with a company policy and management approach built for sustainable career satisfaction /li /brliHealth insurance and a culture geared toward health and well‑being /li /brliAn amazing collaborative team that is diverse, talented, and ready to celebrate success /li /br /ul /brh3About our company: /h3 /brpSuma 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, RD Engineering, and Quality. For additional information about Suma Medtec, we invite you to visit our website: /p /brpSuma 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 /brpPlease note that applications received through third‑party staffing or recruiting companies will not be considered. /p /p #J-18808-Ljbffr

📌 Medical Device Development Lead (Barcelona)
🏢 Suma Medtec
📍 Barcelona