Engineer II, Systems

JOB LOCATION:

Bangalore, India

JOB TITLE:

JOB SUMMARY:

Drives end-to-end product technical success through system architecture design, requirements development, risk analysis, and integration across hardware, software, and firmware. Ensures regulatory compliance by managing documentation, verification and validation, usability engineering, and cross-functional collaboration with R&D, design, quality, and regulatory teams—supporting audits, post-market activities, and external testing aligned with medical device standards

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsible for overall product technical success
Develop user and product requirements and specifications for system based on user needs, product and process regulatory standards.
Compiles and evaluates design and test data, prepares technical specifications, and determines appropriate limits and variables for product, process, or materials specifications.
Develop design inputs based on inputs from other functional engineering group.
Analyse product requirements and other technical specifications to determine if product is performing to requirements.
Develop system architecture.
Define and manage system interfaces and ensure effective system integration across hardware, software, and firmware components.
Achieve best practices that meet medical device industry standard, including design control and documentation.
Interface with product team members, mechanical and electrical engineers, manufacturing or design transfer engineer, R&D, marketing, regulatory (internal).
Analyses, develops, and recommends design approaches required to meet design and production requirements for new or enhanced device.
Collaborate with V&V teams to define test strategies and ensure complete coverage of requirements.
Manage traceability between design inputs, design outputs, and verification and validation.
Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services.
Conduct risk analysis and develop risk management plans to ensure product safety and effectiveness. Identify and mitigate risks associated with the product design and development.
Conduct Usability Engineering activities.
Create and maintain technical documentation such as design specifications, user manuals, and Quick Reference Guide.
Participate in technical reviews and support internal/external audits.
Participate in post-market surveillance, complaint analysis, and field issue resolution.
Coordinate and support external testing activities required for regulatory compliance, including but not limited to safety, EMC, environmental, biocompatibility, usability, software, and cybersecurity testing, in alignment with applicable standards and protocols.

EDUCATION AND/OR EXPERIENCE:

COMPENTENCIES:

Knowledge of medical device technology, applicable quality and safety standards, and regulations (ISO 60601-x)
Demonstrated ability to deal with a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments.
Strong analytical, problem-solving, and interpersonal communication skills.
Familiarity with engineering change control processes and change impact assessment.
Demonstrated initiative, attention to detail, customer focus, and commitment to ongoing process improvement.
Experience with requirements specification and traceability.
Experience in creating and maintaining Design History File (DHF) elements including System Requirements Specification (SyRS), Risk Management File (RMF), and Usability Engineering File.
Knowledge of product life-cycle management.
Experience with project management a plus.
Experience with documentation of design/development activities.
Understanding of medical devices and human respiration system.
Experience in risk management and ISO 14971 is added advantage.
Knowledge of FDA regulations and Medical Devices Directive 93/42/EEC.
GDP & GMP Experiences (Good Documentation Practice & Good Manufacturing practice.

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