2+ FMEA Jobs in Bangalore (Bengaluru) | FMEA Job openings in Bangalore (Bengaluru)

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.

In-depth knowledge in Healthcare and BPaaS domain, Good understanding in Delivery Excellence Framework, Expertise in business and IT processes, platforms, operations, controls and dependencies Secondary Skills: Intermediate to Expert proficiency in conducting audits & assessments in BPaaS domain areas, Proficiency in building, monitoring and testing controls for BPaaS

• Provide facilitation to ensure noiseless delivery and enable best practices adoption & evangelization through appropriate processes and platforms
• Solution consultant for projects to adopt right tools and measure to ensure product & service quality in the appropriate service lines
• Ensure effective governance of projects and deliverables
• Proactive risk management and mitigation, build known risks database to identify and mitigate risks proactively and establish oversight to monitor quality, targets and spending on implementation plan
• Enabling and co-working with the accounts / projects in compliance of regulatory requirements, other certification requirements of the Organization and the Customers for BPaaS domain. Support closure of external/internal audit findings, RCA/CAPA/FMEA for escalations
• Establish Integrated Risk and Delivery Governance models, and oversight to monitor quality, targets, overrun and penalty
• Build process mapping for BPaaS describing the high level activities across Product Service Lines establish ETVX, role definition, gating criteria, SLAs, OLAs and RACI
• Design and ensure operational and compliance controls are implemented, tested and monitored
• Build core competency to carry out DEx BPaaS audits and assessments