Galaxi Consulting Group
Website:
galaxiconsulting.com
Job details:
🚨 HIRING: SYSTEM ENGINEER – MEDICAL DEVICES | PUNE 🚨
We are hiring System Engineers with strong experience in the Medical Device domain for an urgent requirement in Pune.
📍 Location: Pune
💼 Experience: 5–12 Years
👥 Open Positions: 18
⏳ Notice Period: Immediate to 30 Days
🎓 Qualification: B.E./B.Tech/M.E./M.Tech/M.Pharma/M.Sc.
🏥 Domain: Medical Devices – MANDATORY
🔑 Mandatory Skills
✅ System Engineering
✅ DHF Remediation
✅ Gap Assessment
✅ V-Model
✅ Requirements Traceability Matrix (RTM)
✅ Requirements Drafting
✅ DFMEA
✅ Design Control / Design History File
✅ Risk Management
✅ Medical Device Regulatory Documentation
📌 Role Highlights
The role involves supporting EU MDR 2017/745 remediation programs for Class I, II and III medical devices.
Candidates should have hands-on experience in:
• DHF remediation and design-control documentation
• System/product requirements engineering
• Requirements traceability and RTM
• Gap assessment and remediation
• DFMEA and risk-management activities
• V-Model lifecycle
• Technical documentation and compliance activities
• Cross-functional collaboration with R&D, Quality and Regulatory teams
Knowledge of EU MDR 2017/745, ISO 13485 and ISO 14971 will be highly relevant.
💰 Budget
5–8 Years: Approx. ₹1.01 Lakh/month
9–12 Years: Approx. ₹1.17 Lakh/month
⚠️ Medical Device domain experience is mandatory.
Candidates without relevant Medical Device experience may not be considered.
📩 Interested candidates: Please share your updated CV along with:
- Total Experience
- Relevant Medical Device Experience
- Current Location
- Notice Period
- Current/Expected Compensation
- Contact Number
- Email ID
📢 Please share/refer suitable profiles in your network.
Click on Apply to know more.
