01
EU MDR 2017/745
Required
TRCD-26-05031
Systems Engineer (EU MDR Remediation) - Medical Devices
Systems Engineer needed to support EU MDR 2017/745 remediation for Class I/II/III medical devices. The role focuses on gap assessments, design control/DHF remediation, requirements drafting and management, building and maintaining requirements traceability matrices, and applying V-model development practices. You will also support risk management activities (e.g., DFMEA) and update technical documentation to align with EU MDR, ISO 13485, ISO 14971 and applicable product standards, working cross-functionally with R&D, Quality/RA and other stakeholders.
Position summary
- Location
- India
- Workplace
- On-site
- Employment
- Contract
- Experience
- Minimum 5 years and Maximum 12 years
Role overview
Why This Role Matters.
Systems Engineer needed to support EU MDR 2017/745 remediation for Class I/II/III medical devices. The role focuses on gap assessments, design control/DHF remediation, requirements drafting and management, building and maintaining requirements traceability matrices, and applying V-model development practices. You will also support risk management activities (e.g., DFMEA) and update technical documentation to align with EU MDR, ISO 13485, ISO 14971 and applicable product standards, working cross-functionally with R&D, Quality/RA and other stakeholders.
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.
Technology stack
Tools & Technologies.
The platforms and technologies you'll use to build modern, enterprise-grade solutions.
02
MDR remediation
Required
03
DHF
Required
04
Design History File
Required
05
Design controls
Required
06
Gap assessment
Required
07
V-model
Required
08
Requirements engineering
Required
09
Requirements drafting
Required
10
RTM
Required
11
Requirements Traceability Matrix
Required
12
Traceability
Required
13
DFMEA
Required
14
FMEA
Required
15
ISO 13485
Required
16
ISO 14971
Required
17
Risk management
Required
18
Technical documentation
Required
19
Class I
Required
20
Class II
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 devices domain experience (mandatory)
EU MDR 2017/745 remediation support
System engineering / Systems engineering
DHF remediation / Design History File remediation
Gap assessment (compliance/design control gaps)
V-model development lifecycle knowledge
Requirements drafting / requirements engineering
Requirements Traceability Matrix (RTM) / traceability management
DFMEA (Design Failure Modes and Effects Analysis)
Preferred
Nice to Have
ISO 13485 knowledge
ISO 14971 risk management knowledge
Design controls / technical documentation updates
Class I/II/III medical device documentation exposure
Cross-functional collaboration with RA/QA/R&D
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 Systems Engineer (EU MDR Remediation) - Medical Devices
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