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.
Shubham Vishwakarma
Full Stack Developer - Averlon
About NeoGenCode Technologies Pvt Ltd
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.
Candid answers by the company
IT & Engineering Talent Staffing
- Provides full-time and contract-based hiring, delivering handpicked, pre‑screened developers across tech stacks—ranging from web, mobile, AI/ML, Web3/blockchain.
- Maintains a bench o vetted candidates, offering fast delivery of interview-ready profiles—often within 24 hours.
- Offers payroll management, handling compliance, tax, attendance, and documentation for both contractors and full-time employees.
2. End-to-End Project Delivery
- Delivers full-stack development solutions: web, mobile, cloud, AI/ML, Blockchain/Web3.
- Manages entire project lifecycle—requirements gathering, design (UI/UX), development, deployment, and ongoing support .
3. Additional Offerings
- Expands into cybersecurity consulting, digital marketing, and cloud platform services (like AWS, GCP, Azure) .
- Provides strategic IT consulting to align technology solutions with business objectives
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