Engineering Director Medical Device
hace 4 días
Grenoble
UroMems is a pioneering company in the design, development, and commercialization of the active implantable medical device, transforming the management of urological disorders. Why join us? Innovation at the heart of our DNA: At UroMems, we work on disruptive clinical solutions addressing major medical needs, with a direct impact on improving patients' quality of life. Born in the heart of the French Alps in Grenoble, we operate in one of the most dynamic environments for medical technologies, benefiting from a world-class research and innovation ecosystem. A significant impact: Our devices address highly prevalent pathologies and crucial patient issues, giving profound meaning to every mission we undertake. About the role The Director of Engineering will lead a portion of the engineering organization in the design, development, and delivery of innovative medical technologies aligned with company objectives and regulatory standards. This role combines strategic leadership with hands‑on technical oversight. The Director of Engineering will build and scale the engineering team, establish high‑quality development processes, ensure product reliability and regulatory compliance, and collaborate closely with other engineering leaders, Quality, Clinical, and Operations. Engineering Leadership & Strategy • Define and execute the engineering vision, technical and technical strategy aligned with company goals., • Build, lead, and mentor a multidisciplinary engineering team (systems, hardware, and test)., • Establish engineering KPIs and ensure continuous improvement through improvement programs that leverage ongoing development activities., • Regularly report on the progress, risks, and performance of engineering activities to the leadership Product Development & Technical Execution • Oversee architectural development, requirements flow, and relevant systems engineering tasks., • Partner with the PMO and other disciplines in the oversight and throughout the product lifecycle from concept to end-of-life., • Ensure products meet performance, safety, and reliability standards in a regulated MedTech environment., • Implement and improve engineering processes aligned with ISO 13485, and other applicable development standards., • Drive robust system architecture, hardware integration, verification & validation processes., • Lead incident resolution, root‑cause analysis, provide mentoring and engineering support. Cross‑Functional Collaboration • Work closely with Product Management to translate clinical and user needs into technical requirements., • Partner with Quality & Regulatory Affairs to ensure alignment with QMS, documentation, and audits., • Support Operations and Manufacturing Engineering to ensure smooth transition to production and scalability., • Collaborate with firmware, software and engineering test groups in development, integration and verification activities., • Collaborate with the Clinical team, Marketing and Medical Officers to support product trials, feedback loops, and improvements. Organizational Growth & Culture • Develop a high‑performance engineering culture based on transparency, accountability, and innovation., • Introduce best‑practice development methodologies (Agile, CI/CD, design controls)., • Ensure team skills grow in pace with product complexity and company scale., • Foster collaboration between the teams —hands‑on, resourceful, and solution‑oriented. Compliance & Quality • Ensure engineering activities comply with all relevant regulatory frameworks., • Oversee design documentation, DHF/DMR, and discipline related risk management and traceability., • Serve as a technical representative during audits, regulatory submissions, and technical inquiries. Resources & Budget • Define resource and workload plans aligned with product and company growth., • Recruit, onboard, and develop internal engineering resources as required to execute the product roadmap., • Manage the department budgets and financing plans with the company leadership., • Coordinate and supervise external partners and subcontractors to ensure quality, performance, and contractual compliance Requirements: • 10+ years of engineering experience in the medical device industry, including 5+ years in managerial roles., • Proven experience delivering medical devices or health‑tech products in regulated environments., • Strong systems engineering background and proven track record in a mechanical, electrical or systems engineering discipline as a developer., • Strong technical background in hardware and systems engineering for the medical device industry, • Deep understanding of design controls, quality systems, and standards (ISO 13485, ISO 14 708, IEC 60601, IEC 62366, ISO 14971 et al), • Proven and significant experience in team management, • Experience with FDA submissions (PMA, 510(k), De Novo)., • Background in cloud technologies, AI/ML in healthcare, cybersecurity, • Excellent communication and written skills in English (B2-C1) What we propose: • CDI contract, • Competitive salary and package, • FMD ( Forfait Mobilite Durable), • Meal vouchers- 10 euro per day, • A flexible remote work policy ( 2 days per week), • CSE benefits, • International environment Join UroMems and be part of the medical technology revolution in urology!
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