Position Overview:
We are looking for a talented and detail-oriented Requirements Engineer with a strong focus on Medical Devices Software to join our dynamic team. The successful candidate will be responsible for capturing, analyzing, and managing software requirements for medical devices. This critical role involves collaborating with cross- functional teams to ensure software products meet both regulatory standards and functional specifications.
Key Responsibilities:
Requirement gathering and Analysis:-Gather, define, and document both functional and non-functional software requirements for medical devices, ensuring compliance with medical standards (e.g., FDA, ISO 13485). Work closely with stakeholders, including clinical staff, R&D, product managers, and regulatory teams to, understand user needs, technical constraints, and regulatory requirements. Translate business and technical needs into clear, actionable software requirements that align with the product development lifecycle.
Collaboration with Cross-Functional Teams:- Partner with software developers, quality assurance teams, regulatory affairs, and project managers to ensure requirements are understood and integrated into the design and development processes.- Support the software development team by providing clear and concise requirement specifications, use cases, user stories, and system specifications. -Facilitate communication between internal teams and external stakeholders (such as suppliers and regulatory bodies) to ensure alignment on software requirements.
Regulatory Compliance and Risk Management:-Ensure all software requirements comply with relevant regulations such as FDA, ISO 13485, IEC 62304, and other applicable standards for medical software. Participate in risk management activities, including risk assessments (e.g., FMEA), and ensure that safety and regulatory concerns are addressed within software requirements.
Continuous Improvement:-Contribute to the ongoing improvement of the requirements management process. Stay up-to-date with the latest trends and regulatory changes in the medica device software industry to ensure best practices and compliance. Continuously evaluate and improve documentation quality, requirements gathering methods, and communication processes.
Mandatory Skills:
Excellent knowledge of medical device software regulations (e.g., FDA, ISO 13485, IEC 62304, HIPAA, Interoperability standards).
Strong technical writing skills with the ability to produce clear, well-documented requirements, user stories, and technical specifications.
Strong communication skills and the ability to work effectively with multidisciplinary teams.
Familiarity with software testing and validation techniques for medical devices.
Preferred Skills:
Experience with embedded software or real-time systems.
Familiarity with software version control systems (e.g., Git, SVN).
Experience with software project management tools (e.g., Jira, Confluence).
Knowledge of risk management processes (e.g., FMEA, fault tree analysis).
Understanding of UX/UI principles and how they apply to medical device software design.
Qualifications:
Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, Medical Electronics, Bachelor’s or Master’s degree in Pharma or related technical field. Additional certifications in medical device software (e.g., ISO 13485, IEC 62304) are a plus.
3–8 years of experience as a Requirements Engineer, preferably in medical device software development or other regulated industries (e.g., automotive, aerospace).
Experience with software development lifecycle (SDLC) methodologies such as Waterfall, Agile, or V-Model.
Strong experience in creating and managing software requirements for complex systems, especially in regulated environments.
If you bring rigorous passion, and ambitious vision to building ground-breaking systems, we invite you to apply now