Requirement Engineer – Medical Devices Hardware
Position Overview:
We are seeking a highly skilled and detail-oriented Requirement Engineer for Medical Devices Hardware to join our innovative team. The successful candidate will be responsible for defining, documenting, and managing the hardware requirements for medical devices. This role is critical ensuring that hardware products meet both functional and regulatory standards for safety, performance and quality in the medical device industry.
Key Responsibilities:
Requirement Gathering and analysis:- Elicit, document, and maintain detailed functional, non-functional, and regulatory requirements for hardware components of medical devices.-Work with stakeholders to understand user needs, system constraints, and technical specifications.-Ensure all requirements are traceable, verifiable, and clearly documented using established standards and methodologies.
Collaboration with Cross-Functional Teams:-Collaborate with hardware, software, quality assurance, regulatory, and R&D teams to ensure alignment of requirements with product specifications. Support design and development teams in interpreting requirements during the design, testing, and validation phases. Engage with suppliers and external partners to gather technical inputs and ensure compliance with product requirements.
Regulatory Compliance:- Ensure that all hardware requirements comply with industry regulations (e.g., FDA, ISO 13485, IEC 60601) and maintain knowledge of relevant standards. Support the creation of technical documentation required for regulatory submissions and audits.
Verification and Validation:-Work with testing teams to define hardware validation and verification plans, ensuring requirements are met throughout the product lifecycle. Support the execution of verification activities to confirm the hardware meets all functional and regulatory requirements.
Risk Management:-Contribute to risk assessments and mitigation strategies related to hardware performance, safety, and reliability. Ensure that all hardware requirements address potential hazards and include safety measures in compliance with applicable standards.
Continuous Improvement:-Actively participate in continuous improvement initiatives to enhance the requirements engineering process. Keep up-to-date with technological advancements and best practices in the medical device industry, particularly related to hardware engineering.
Mandatory Skills:
Minimum of 3–8 years of experience in requirements engineering, preferably in the medical device or regulated industry.
Experience with medical hardware systems, including components such as sensors, actuators, microcontrollers, and analog/digital circuitry.
Familiarity with hardware development lifecycle and methodologies such as V-Model, Agile, or Waterfall.
Strong understanding of regulatory standards (e.g., FDA, ISO 13485, IEC 60601) and their application in medical device development.
Excellent documentation skills, including the ability to write clear, concise, and detailed requirement specifications.
Strong problem-solving and analytical skills with the ability to manage complex technical details and trade-offs
Ability to work effectively in a cross functional team environment, with strong interpersonal and communication skills.
Preferred skills:
Familiarity with hardware design tools and CAD software (e.g., Altium Designer, SolidWorks).
Experience in medical device risk management processes (e.g., FMEA, fault tree analysis).
Knowledge of embedded systems and hardware/software interfaces.
Qualifications:
Bachelor’s or Master’s degree in Electrical Engineering, Biomedical Engineering, Medical electronic and instrumentation Engineering, or a related technical field. Additional certifications in medical device development (e.g., Certified Quality Engineer, ISO 13485) are a plus.
3-8 Years of Relevant experience.
If you bring rigorous passion, and ambitious vision to building ground-breaking systems, we invite you to apply now
info.connect@visukhi.com