2+ Medical devices Jobs in Bangalore (Bengaluru) | Medical devices 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.

• Support the transition by planning and overseeing the transfer of members from one location to another, including but not limited to operational readiness, support documentation, knowledge transfer and acceptance checklists
• Support in ensuring transition activity is planned and executed to schedule, budget and scope
• Support in establishing transition end to end plans including infrastructure support models, change management, risk assessment and mitigation, resource planning and service management with clear tollgates
• Liaise with transition lead on milestone scheduling, knowledge transfer activities, and communication of progress (KPIs)
• Keep stakeholders involved in transition process and update them with the progress and roadblocks
• Promote awareness of transition planning and support processes within the GCC
• Support the Transition Lead to source and assess opportunities to expand the centre (including assessment of Make vs. Buy, offshore / on shore)
• Work directly with third party resources on a day-to-day basis to support the transition process during the set-up of the GCC

Skills:

• Proven knowledge of service transition methodology, tools and templates through experience or qualifications
• The ability to identify, escalate and manage project risks with the Transition Lead
• 3+ years of experience transitioning / offshoring / outsourcing projects / functions across sub processes such as Biostatistics, reg. affairs, clinical ops, drug safety, medical Governance, strategy and planning, pharma covigilance
• Good exposure in previous roles to multi-cultural, transversal functions
• Pharma background with experience across the systems development life cycle with experience in different project phases
• Excellent written and verbal communication skills – must be able to communicate fluently in English both verbally and in writing