01
TRCD-26-04939
Test Engineer – DHF Remediation / EU MDR (Medical Devices)
Contract Test Engineer (4–8 years) needed in Pune to support Design History File (DHF) remediation and EU MDR 2017/745 compliance for medical device software. The role focuses on reviewing design documentation for gaps, creating/updating and executing verification & validation (V&V) protocols, maintaining traceability (requirements–risk–design–test evidence), managing defects in tools like Jira/ALM/Azure DevOps, and supporting design reviews/audits under standards such as IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR Part 820.
Position summary
- Location
- India
- Workplace
- On-site
- Employment
- Contract
- Experience
- Minimum 4 years and Maximum 8 years
Role overview
Why This Role Matters.
Contract Test Engineer (4–8 years) needed in Pune to support Design History File (DHF) remediation and EU MDR 2017/745 compliance for medical device software. The role focuses on reviewing design documentation for gaps, creating/updating and executing verification & validation (V&V) protocols, maintaining traceability (requirements–risk–design–test evidence), managing defects in tools like Jira/ALM/Azure DevOps, and supporting design reviews/audits under standards such as IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR Part 820.
Your Impact
Deliver Enterprise Value
Help organisations solve complex business problems through modern technology, consulting expertise and measurable outcomes.
Collaboration
Work Across Teams
Collaborate with consultants, architects, engineers and client stakeholders throughout the project lifecycle.
Growth
Learn Continuously
Gain exposure to enterprise technologies, certifications, mentoring and real-world project experience.
Career Path
Grow With Ubique
Build a long-term consulting career with opportunities to take on greater responsibility and leadership over time.
Responsibilities
What You'll Be Doing.
Every role at Ubique contributes directly to solving meaningful business challenges for our clients.
02
Review design documentation to identify gaps against regulatory requirements.
03
Create, update, and execute verification and validation (V&V) test protocols.
04
Develop and maintain test cases, test procedures, and traceability matrices.
05
Execute functional, system, regression, integration, and compatibility testing.
06
Analyze test results, document defects, and work with development teams for resolution.
07
Ensure complete traceability between requirements, risks, design outputs, and test evidence.
08
Software Requirements Specification (SRS)
09
Participate in design reviews and regulatory audits.
10
Support defect management using tools such as Jira or ALM.
11
Ensure compliance with company quality processes and regulatory standards.
12
Strong understanding of DHF remediation activities.
Technology stack
Tools & Technologies.
The platforms and technologies you'll use to build modern, enterprise-grade solutions.
01
DHF
Required
02
Design History File
Required
03
EU MDR
Required
04
EU MDR 2017/745
Required
05
IEC 62304
Required
06
ISO 14971
Required
07
ISO 13485
Required
08
FDA 21 CFR Part 820
Required
09
QMS
Required
10
SRS
Required
11
Software Requirements Specification
Required
12
SDD
Required
13
Software Design Description
Required
14
V&V
Required
15
Verification and Validation
Required
16
RTM
Required
17
Traceability Matrix
Required
18
Risk Management
Required
19
Risk-based testing
Required
20
Jira
Required
Requirements
Skills & Experience.
We value curiosity, collaboration and continuous learning. If you don't meet every requirement but believe you can make an impact, we'd still love to hear from you.
Essential
Required Qualifications
DHF (Design History File) remediation for medical devices
EU MDR remediation / compliance (EU MDR 2017/745)
Verification & Validation (V&V) testing (protocols, execution, reporting)
Test case/test procedure development and execution (functional, system, regression, integration, compatibility)
Requirements traceability (RTM) and end-to-end traceability (requirements, risks, design outputs, test evidence)
Risk-based testing concepts and application
Knowledge of medical device software SDLC
IEC 62304 knowledge
ISO 14971 knowledge (risk management)
ISO 13485 knowledge (QMS)
FDA 21 CFR Part 820 / QMS knowledge
Defect management using Jira and/or ALM and/or Azure DevOps
Strong documentation skills (SRS, SDD, V&V reports, risk docs)
Preferred
Nice to Have
IEC 60601 knowledge (preferred per JD)
Experience participating in regulatory audits and design reviews
Compatibility testing experience across environments/configurations
What you'll gain
More Than Just A Job.
We're committed to helping every team member grow professionally, personally and technically while working on meaningful projects.
Global Exposure
Collaborate with international clients and multicultural teams on enterprise programmes.
Continuous Learning
Expand your expertise through mentoring, certifications and hands-on project experience.
Career Growth
Take ownership, develop leadership skills and grow your consulting career over time.
Flexible Working
Hybrid and remote collaboration designed around trust and delivering exceptional outcomes.
People First
Join a supportive culture where collaboration, respect and long-term relationships come first.
Enterprise Projects
Work on meaningful technology initiatives for leading organisations across industries.
Apply
Apply for Test Engineer – DHF Remediation / EU MDR (Medical Devices)
One page, about two minutes. We only ask for what we actually need to have a first conversation.