01
TRCD-26-06167
DHF Remediation Engineer (Medical Devices)
Contract role in Pune for a DHF Remediation Engineer to assess and remediate medical device Design History Files and design control documentation. The person will perform DHF gap assessments, update design control artifacts (user needs through design transfer), ensure end-to-end traceability, and author/review verification and validation protocols and reports. The role requires strong working knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, and FDA 21 CFR 820/QMSR, plus collaboration with R&D, Quality, Regulatory, and Clinical teams; immediate to 30 days notice preferred.
Position summary
- Location
- India
- Workplace
- On-site
- Employment
- Contract
- Experience
- Minimum 4 years and Maximum 9 years
Role overview
Why This Role Matters.
Contract role in Pune for a DHF Remediation Engineer to assess and remediate medical device Design History Files and design control documentation. The person will perform DHF gap assessments, update design control artifacts (user needs through design transfer), ensure end-to-end traceability, and author/review verification and validation protocols and reports. The role requires strong working knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, and FDA 21 CFR 820/QMSR, plus collaboration with R&D, Quality, Regulatory, and Clinical teams; immediate to 30 days notice preferred.
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
Design Controls
03
Technical Documentation Review
04
Requirements Traceability
05
Verification & Validation Documentation
06
Root Cause Analysis
07
Medical Device Product Development Lifecycle
08
Perform detailed gap assessments of legacy and active DHF documentation.
09
Review and remediate
10
Intended Use Statements
11
Product Requirements
12
Design Review Records
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
DHF remediation
Required
04
Design Controls
Required
05
Design Control
Required
06
Traceability Matrix
Required
07
RTM
Required
08
Verification Protocol
Required
09
Verification Report
Required
10
Validation Protocol
Required
11
Validation Report
Required
12
EU MDR 2017/745
Required
13
MDR 2017/745
Required
14
ISO 13485:2016
Required
15
ISO 14971
Required
16
FDA 21 CFR Part 820
Required
17
QMSR
Required
18
IEC 62366
Required
19
IEC 60601
Required
20
Technical File
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
Medical device domain experience
DHF remediation (Design History File remediation)
Design controls / design control documentation
Technical documentation review and remediation
Requirements traceability / traceability matrix (RTM)
Verification & Validation documentation (protocols, reports)
Verification testing and reporting
Protocol drafting (verification/validation)
Root cause analysis
Medical device product development lifecycle knowledge
Working knowledge of EU MDR 2017/745
Working knowledge of ISO 13485:2016
Working knowledge of ISO 14971
Working knowledge of FDA 21 CFR Part 820 / QMSR
Preferred
Nice to Have
IEC 62366 usability engineering knowledge
IEC 60601 series awareness (electrical medical devices)
Risk management documentation (Risk Management Plan, Hazard Analysis, DFMEA, Use FMEA, benefit-risk)
Technical file remediation (Annex II/III)
PMS documentation review
PMCF documentation support
Labeling/IFU remediation
Support for Notified Body observations and responses
Experience with PLM/QMS tools (Windchill PLM, Agile PLM, Teamcenter, TrackWise)
Microsoft Office Suite
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 DHF Remediation Engineer (Medical Devices)
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