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.

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