? HIRING: SYSTEM ENGINEER – MEDICAL DEVICES | PUNE ?

We are hiring System Engineers with solid 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.

📌 System Engineer (Solapur)
🏢 Galaxi Consulting Group
📍 Solapur