Job Description

Experience Minimum 5+ years of experience in developing medical device software compliant with IEC 62304:2006 / AMD 1:2015 Software life cycle processes for medical devices standard. Development of software to a similar standard or level of rigor also acceptable (e.g. aerospace). Background in risk management processes, including FMEA (Failure Mode and Effects Analysis). Expertise in utilizing FMEA to analyze potential failure modes, prioritize risks, and develop robust mitigation strategies. Functional knowledge of ISO 14971:2019 Application of risk management to medical devices standard. Experience in defining and documenting system and subsystem requirements for complex systems and software solutions. Proficient in adhering to ISO/IEC/IEEE 29148:2018 Systems and software engineering standard to ensure comprehensive and structured requirements engineering. Expert in requirements traceability management tools to manage requirements and traceability between requirements, design elements, software test artifacts, interface controls, risk control measures, and outputs. Demonstrated success delivering large complex projects across the entire lifecycle. Skills • Attention to Detail: Meticulous attention to detail in all tasks and projects. • Behavioral Modeling: Consistently model exceptional behaviors, contributing to a positive and productive work environment and a culture of integrity and excellence. • Change Leader: Change leader who identifies opportunities for improvement and implements solutions to drive positive change. • Collaboration and Team Contribution: Skilled in fostering open communication and collaboration, encouraging input from others and contributing to a positive team environment. • Communication and Presentation: Clear communication and effective presentation skills, capable of delivering technical information to both technical and non-technical audiences and adept at responding to inquiries from various stakeholders. • Communication Skills: Superior written and verbal communication abilities, ensuring clear and effective communication of complex information across diverse audiences. • Critical Thinking: Apply critical thinking skills to analyze problems and develop innovative solutions. • Decision-making and Problem Solving: Proficient in identifying and resolving issues promptly. Make timely decisions involving appropriate stakeholders, ensuring efficient problem resolution and project execution . • Effective Communication: Proven ability to communicate effectively both verbally and in writing, fostering strong relationships and clear understanding. • Lab environment: Should not be sensitive to the sight or discussion of blood or needles. Both human and bovine blood is used where necessary, in addition to visiting customer sites where our equipment is used in a clinical or donor environment