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Business Analyst

Role Overview

•Position: Business Analyst (BA)

•Band / Level: B4 Band

•Experience: 5 to 7 Years

•Contract Duration: 4 Months (Extendable based on project requirements)

•Location: Pune (Work from Office)

Position Summary

We are seeking a seasoned Business Analyst (B4 Band) with 5-7 years of experience to join our team for a fast-paced, 4-month critical project phase. The ideal candidate will bridge the gap between business stakeholders and tech teams, rapidly gathering requirements, mapping workflows, and translating complex business logic into actionable technical specifications.

Key Responsibilities

•Requirement Engineering: Lead requirement gathering sessions with client stakeholders, business owners, and technical teams to define clear project scope.

•Documentation: Create comprehensive Business Requirement Documents (BRDs), Functional Specification Documents (FRDs), User Stories, and Process Flow diagrams.

•Sprint Readiness: Work closely with Scrum Masters and Product Owners to build, groom, and prioritize the product backlog with well-defined acceptance criteria.

•Gap Analysis: Perform detailed impact and gap analysis on existing systems to ensure new features align with current architecture.

•Stakeholder Management: Manage expectations across multi-functional teams, acting as the primary functional point of contact during the 4-month delivery sprint.

Mandatory Skills & Qualifications

•5-7 years of core Business Analyst experience in a software development environment.

•Proven track record of working in Agile/Scrum frameworks.

•Strong proficiency in documentation tools (Jira, Confluence, Miro, or Visio).

•Exceptional communication, analytical framework skills, and the ability to simplify complex business scenarios for development teams.

•Ability to work autonomously and adapt to a short-term, fast-paced contract environment.

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.