System Requirements Engineer

System Engineer /Sr. Systems Engineer

Location: Pune, India

Company: InnoIQ Engineering (Subsidiary of B&W Engineering und Datensysteme GmbH, Germany)

Industry: Medical Devices / Engineering Services

Employment Type: Full-time

Role Summary:

We are seeking a meticulous and detail-oriented System Engineer to join our growing team. In this role, you will be responsible for translating product needs into clear, structured, and testable requirements and specifications that guide engineering teams through the development of medical devices. You will act as a critical bridge between product management, design, and engineering teams, ensuring that all stakeholder needs are accurately captured and documented.

About Us:

At InnoIQ Engineering, a proud subsidiary of B&W Engineering und Datensysteme GmbH, Germany, we specialize in the research, design, and development of innovative medical devices. Guided by German engineering principles and a deep understanding of global healthcare needs, we deliver precision, quality, and customer-centric solutions. From early concept to production support, we serve as a strategic engineering partner to leading medical technology companies.

TitleSystem Engineer /Sr. Systems EngineerQualificationBachelors or masters degree in Biomedical/ Electronics/Electronics & Telecommunication/Computer/Mechatronics EngineeringExpected Experience

• 5-10 Years of Relevant Experience with minimum 3 years in medical device or other regulated industry
• Experience in New Product Development (NPD)/New product Introduction and Sustenance Engineering is a must

Job Responsibilities

• Derives requirements from high -level requirements into product level requirements.
• Develop clear, concise, and testable specifications for hardware and software components of medical devices.
• Collaborates with multiple teams including client team, marketing/business development teams, technical teams, quality and regulatory teams to decompose needs statements into system product level requirements for medical devices and accessories
• Maintain traceability matrices and ensure alignment with verification and validation plans
• Participates in design reviews, including reviews of design inputs and outputs to ensure requirements are feasible and aligned with product goals.
• Keeps abreast of new developments in all relevant technological domains
• Envision, Desing, Build innovative solutions for customer Needs, Product & Services Ideation and conceptualization.
• POC development and prototyping
• Actively participates in design fraternity by sharing and learning best practices and gets involved in other organization initiatives

Required Skills

• In-depth understanding of both hardware and software for integrated products
• Experience with tools such as DOORS, Jama, Polarion, or equivalent is a plus.
• Experience with embedded microprocessors and microcontrollers
• Experience with Product Design
• Hands on with ADC/DAC/Chemical Sensors
• Knowledge of IOT, Bluetooth, Wi-Fi, USB, File System for Embedded Platform
• Knowledge of global quality and regulatory environment for Medical devices including , FDA, EU MDR, MDD, IEC CE marking), ISO 13485, IEC 62304, ISO 14971
• Strong understanding of Safety risk management, including FMEA, design mitigations, and risk management standards
• Strong Customer facing skills
• Effective verbal/written communication, documentation, presentation and interpersonal skills, as well as the ability to work both independently and as part of team

Desirable Skills

• Firmware Experience with RTOS or Baremetal
• System level Circuit Modeling with EDA tools(or similar). SPICE
• Design of experiment (DOE) methodologies
• Design for excellence viz DFM, DFT, DFR
• Usability aspects of Medical devices according to HFE/HE75. IEC 62366, IEC etc

What We Offer:

• Opportunity to work on cutting-edge medical technologies.
• Involvement in meaningful projects that directly impact patient care and quality of life
• A collaborative and innovation-driven work culture.
• Exposure to international projects and clients.
• Professional development and training programs.
• Flexible working hours / Hybrid work / International team / Training programs, etc
• Competitive compensation and benefits.