R&D System Engineer
פורסם 28 ביוני · 0 מועמדים
התפקיד במילים פשוטות
התפקיד כולל תמיכה בפיתוח ובניהול מחזור החיים של מכשיר רפואי מבוסס תוכנה, כולל ניתוח נתוני שטח ובניית לוחות בקרה פנימיים. בנוסף, התפקיד דורש תכנון וביצוע של פרוטוקולי אימות ותיקוף (V&V) ועבודה צמודה עם צוותי תוכנה, בקרת איכות ורגולציה.
- BSc in Engineering (Biomedical, Software, Mechanical, Electrical, or a related discipline)
- 3-5 years of experience in the medical device industry (or another highly regulated field)
- Strong system-level understanding with the ability to see the big picture and bridge hardware, software, and data insights
- Proven experience in execution, with strong organizational skills and attention to detail
- Experience with data analysis tools and methodologies
- Familiarity with Cloud/AWS environments
- Solid understanding of medical device development processes, design controls (ISO 13485, IEC 62304), and V&V principles
חולץ מתיאור המשרה · מתעדכן אוטומטית
למי זה מתאים
משרה זו מתאימה לבעלי תואר ראשון בהנדסה עם 3 עד 5 שנות ניסיון בתעשיית המכשור הרפואי או בתחום מפוקח אחר, בעלי הבנה מערכתית וניסיון מעשי בבדיקות. היא פחות מתאימה למי שמחפש ארגון גדול ומובנה מאוד או למי שאין לו ניסיון קודם בסביבה רגולטורית.
תיאור המשרה המלא
המשרה המקורית · נשמר לעיוןSynchrony Medical has developed LibAirtyTM - an FDA-cleared, at-home airway clearance system for people living with chronic lung disease. Following the successful US Launch of LibAirty, we are now growing and are looking for a hands-on engineer to support R&D, data analysis, engineering and testing activities in a dynamic, fast-paced environment.
What You’ll Do:
• Product Support: Support the product development and lifecycle management of a software-centric medical device.
• Data Insights: Analyze real-world field data to monitor performance, detect trends, and identify opportunities for continuous improvement.
• Tools & Dashboards: Build and maintain internal dashboards and data visualization tools to support engineering and clinical insights.
• V&V Execution: Plan, author, and execute verification & validation (V&V) protocols for system and software features.
• Compliance: Support design controls, Device History File (DHF) documentation, and regulatory compliance activities.
• Cross-Functional Collaboration: Work closely with software, QA/RA, clinical, and field teams to drive product excellence.
What We’re Looking For:
• Education: BSc in Engineering (Biomedical, Software, Mechanical, Electrical, or a related discipline).
• Experience: 3–5 years of experience in the medical device industry (or another highly regulated field).
• Systems Perspective: Strong system-level understanding with the ability to see the big picture and bridge hardware, software, and data insights.
• Hands-on Testing: Proven experience in execution, with strong organizational skills and attention to detail.
• Data Analytics: Experience with data analysis tools and methodologies (familiarity with Cloud/AWS environments is a strong advantage).
• Standards & Regulations: Solid understanding of medical device development processes, design controls (ISO 13485, IEC 62304), and V&V principles highly advantageous.
• Mindset: A proactive team player with a startup mindset who thrives on high ownership and autonomy.
Why Join Us:
• Real Impact: Work on a product that directly improves the daily lives of patients.
• High Ownership: Enjoy a high degree of influence, visibility, and impact within a lean, agile team.
• Broad Exposure: Gain diverse, cross-disciplinary experience across R&D, V&V, data, and systems engineering.
• Growth Opportunity: Scale alongside a growing company entering its next exciting commercial chapter.
שאלות על המשרה
- המשרה לא ציינה שכר. אנחנו מציגים שכר רק כשהמעסיק מפרסם אותו.
- BSc in Engineering (Biomedical, Software, Mechanical, Electrical, or a related discipline), 3-5 years of experience in the medical device industry (or another highly regulated field), Strong system-level understanding with the ability to see the big picture and bridge hardware, software, and data insights, Proven experience in execution, with strong organizational skills and attention to detail, Experience with data analysis tools and methodologies