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TRCD-26-06140
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 engineer will perform DHF gap assessments, update design control artifacts (user needs through design transfer), maintain requirements traceability, and produce verification/validation documentation and reports to support compliance with EU MDR 2017/745, ISO 13485, ISO 14971, and FDA Design Controls, working cross-functionally with R&D, Quality, Regulatory, and Clinical teams.
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 engineer will perform DHF gap assessments, update design control artifacts (user needs through design transfer), maintain requirements traceability, and produce verification/validation documentation and reports to support compliance with EU MDR 2017/745, ISO 13485, ISO 14971, and FDA Design Controls, working cross-functionally with R&D, Quality, Regulatory, and Clinical teams.
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
Design History File
Required
02
DHF remediation
Required
03
Design Controls
Required
04
FDA Design Controls
Required
05
EU MDR 2017/745
Required
06
ISO 13485
Required
07
ISO 14971
Required
08
Risk management
Required
09
Traceability matrix
Required
10
Requirements traceability
Required
11
Verification and Validation
Required
12
V&V documentation
Required
13
Verification testing
Required
14
Verification protocol
Required
15
Verification report
Required
16
Design inputs
Required
17
Design outputs
Required
18
Design review
Required
19
Design transfer
Required
20
Technical documentation review
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 / FDA Design Control requirements
Technical documentation review and remediation
Requirements traceability (traceability matrices)
Verification & Validation (V&V) documentation
Verification testing and verification reporting
Protocol drafting (test/verification protocols)
Root Cause Analysis (RCA)
Medical device product development lifecycle knowledge
Knowledge of EU MDR 2017/745
Knowledge of ISO 13485
Knowledge of ISO 14971
Understanding of design control artifacts (user needs, intended use, design inputs/outputs, design reviews, verification/validation reports, design transfer documentation)
Preferred
Nice to Have
Cross-functional collaboration with R&D, Regulatory Affairs, Quality, Clinical teams
Technical file remediation (as mentioned in overview)
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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