Engineer/Senior Engineer - Digital Quality

Overview

This role is for a digital quality engineering professional supporting a US-based product company in Bengaluru or Gurugram. The position focuses on product quality, compliance, and software lifecycle governance for safety-critical and medical-device-related development work.

The ideal candidate will bring experience in new product development and quality engineering, along with strong exposure to software development lifecycle controls, design reviews, risk management, and regulatory documentation.

Location and experience

• Work location: Bengaluru or Gurugram
• Total experience required: 2 to 8 years
• Notice period expectation: immediate joiners up to a maximum of 30 days

Key responsibilities

• Review and assess risk management artifacts, design inputs, design history file documents, design outputs, test logs, test plans, software verification and validation documents, and product security documentation.
• Take ownership of risk management activities aligned to ISO 14971 to support product safety and effectiveness.
• Ensure that software lifecycle processes are being followed and that the required reviews are completed at the right stages.
• Coordinate quality activities across R&D, testing, regulatory, and post-market quality teams so the product, process, or component remains safe, compliant, and effective.
• Participate in design reviews throughout the new product development cycle.
• Collaborate on verification, validation, and release strategies that improve compliance, safety, reliability, and effectiveness.
• Contribute to the development of sound software architecture in line with quality and regulatory expectations.
• Apply strong knowledge of software engineering standards and risk-management practices, especially for safety-critical environments.
• Use a practical, solution-oriented quality engineering approach that adds value to the business.
• Communicate clearly and work effectively with cross-functional teams.

Requirements

• 2 to 8 years of experience in new product development with a strong focus on quality engineering activities.
• Prior experience in the medical device industry is strongly preferred.
• Bachelor’s degree in Software Engineering, Computer Science, or a related field, along with 4 to 8 years of work experience.
• B.Tech or B.E. in Computer Science or Electronics Engineering.
• Hands-on exposure to the medical device software development life cycle and IEC 62304.
• Experience with new product development and the different phases involved in launching a new product.
• Working knowledge of ISO 14971, IEC 62304, and the 60601-1 family of standards.
• Understanding of quality management systems such as ISO 13485, 21 CFR 820, and ISO 9001.
• Basic familiarity with programming languages, embedded software, and related tools.
• Ability to review defects and participate in detailed engineering reviews.
• Comfort working with software, mechanical, electronic, and material/implant engineering teams using consistent approaches.
• Capability to support specifications, protocols, architecture, detailed design, verification, validation planning, and system test design.
• Ability to conduct and moderate design reviews such as SRS reviews and source code reviews.
• Willingness to help educate teams on engineering processes, documentation discipline, and formal review practices.

Additional information

This opportunity is for a reputed multinational client based in the US and is being shared through a recruiting partner. Applicants are expected to be ready to work from Bengaluru or Gurugram and be available for interviews on weekdays, including face-to-face and MS Teams rounds.

Candidates interested in the role are expected to share an updated profile and provide the following details: total experience, relevant experience in IEC 62304 / Medical Device Software Development / SAMD / SIMD, current CTC, expected CTC, official notice period, readiness to work in Bengaluru/Gurugram, and availability for weekday interviews.

The subject line of the reply should be kept unchanged.

Contact details provided in the source have been omitted here.

Preferred background

Experience in medical-device software quality, embedded software environments, and defect review processes will be advantageous.