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Medical Device Engineer
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Medical Device Engineer

Akshay Patil's profile picture
Posted by Akshay Patil
5 - 10 yrs
₹2L - ₹12L / yr
Bengaluru (Bangalore), Pune
Skills
Medical devices
sustenance
DHF Remediation
ISO 13485
IEC 60601
ISO 14971
FDA
EU MDR
Compliance
FMEA
CTS
CTQ
QMS
Product Lifecycle Management (PLM)
Impact analysis
Verification and validation

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview


Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.


Key Skills & Knowledge :

  • Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
  • Experience with FDA and EU MDR regulatory requirements

Responsibilities :

  • Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
  • Analyze and implement design changes, assess impact, and update documentation accordingly
  • Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
  • Assess compliance with applicable standards and regulations
  • Define CTS/CTQ parameters and actively participate in design reviews
  • Follow QMS guidelines and manage changes through PLM.
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About NeoGenCode Technologies Pvt Ltd

Founded :
2023
Type :
Services
Size
Stage :
Raised funding

About

Welcome to Neogencode Technologies, an IT services and consulting firm that provides innovative solutions to help businesses achieve their goals. Our team of experienced professionals is committed to providing tailored services to meet the specific needs of each client. Our comprehensive range of services includes software development, web design and development, mobile app development, cloud computing, cybersecurity, digital marketing, and skilled resource acquisition. We specialize in helping our clients find the right skilled resources to meet their unique business needs. At Neogencode Technologies, we prioritize communication and collaboration with our clients, striving to understand their unique challenges and provide customized solutions that exceed their expectations. We value long-term partnerships with our clients and are committed to delivering exceptional service at every stage of the engagement. Whether you are a small business looking to improve your processes or a large enterprise seeking to stay ahead of the competition, Neogencode Technologies has the expertise and experience to help you succeed. Contact us today to learn more about how we can support your business growth and provide skilled resources to meet your business needs.

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Shubham Vishwakarma

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