Who We Are : About Noze
Imagine detecting diseases just by smelling someone's breath. It's not science fiction anymore. With every breath, our bodies release a unique 'health snapshot' into the air—a hidden language that has largely gone unnoticed until now. Inspired by nature and enhanced by NASA technology, we've developed the world's first fully-integrated diagnostic breathalyzer. This groundbreaking device can decode these health signals in real-time, right at the point of care, ushering in a new era of healthcare where the sense of smell is at the forefront of medicine.
Who You Are : The Opportunity
We're looking for a highly motivated and experienced Clinical Systems Engineer to join our team in Montréal, Canada. This pivotal role will be instrumental in bridging the gap between clinical needs and technical specifications, ensuring our medical device meets the highest standards of usability, safety, and regulatory compliance.
If you thrive in an early-stage environment, are passionate about making a tangible impact on patient care, and possess a strong systems engineering background in medical devices, join us in shaping the future of healthcare!
What You’ll Do : Key Responsibilities
As a Clinical Systems Engineer, you will:
- Requirements Management & System Definition
Lead the elicitation, analysis, and prioritization of system requirements from diverse stakeholders, including clinicians, researchers, product managers, and regulatory experts.
Translate complex user needs and clinical workflows into clear, concise, and verifiable system specifications.
Develop and maintain comprehensive requirements documentation (e.g., User Requirements Specifications, System Requirements Specifications).
Define and manage the system architecture and design in collaboration with R&D, ensuring alignment with clinical needs and regulatory standards.
Establish and manage traceability between user needs, system requirements, design inputs, and verification activities.
- Clinical Engineering & Application
Apply clinical engineering principles to analyze, evaluate, and optimize system performance from a user and patient perspective.
Collaborate closely with clinical teams to understand real-world clinical challenges and translate them into actionable system improvements.
Participate in the evaluation of system prototypes and early versions in clinical or simulated environments to gather user feedback and identify design gaps.
Contribute to the development of training materials and user guides for clinical staff, ensuring systems are effectively adopted and utilized.
Support post-market surveillance activities by analyzing clinical feedback and identifying potential system enhancements or issues.
- Cross-functional Collaboration & Leadership
Act as the primary technical liaison between Clinical Affairs, Product Development, R&D, QA, and other relevant teams throughout the product lifecycle.
Facilitate effective communication and problem-solving among cross-functional teams to resolve technical challenges related to system requirements and design.
Provide technical leadership and guidance on systems engineering best practices within the Clinical Engineering team and to broader product development efforts.
Champion a user-centric approach to system design, ensuring that clinical usability and safety are paramount.
- Verification & Validation Support
Contribute to the development of test plans and protocols to verify that system requirements are met.
Support validation activities to ensure the system meets clinical needs and intended use.
Participate in design reviews, risk assessments, and usability studies.
- Documentation & Compliance
Ensure all systems engineering documentation adheres to relevant medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820) and internal quality procedures.
Maintain accurate and organized records of all requirements-related activities.
What You’ll Bring : Qualifications & Skills
Essential Skills
Project Management: Ability to manage complex projects, prioritize tasks, and meet deadlines in a fast-paced, dynamic environment.
Communication Skills: Exceptional written and verbal communication skills, including the ability to articulate complex technical concepts to non-technical stakeholders and influence cross-functional teams effectively.
Accountability & Autonomy: Demonstrated ability to take ownership of tasks and projects, work independently, and drive initiatives to completion with minimal supervision.
Analytical & Problem-Solving: Strong analytical abilities to break down complex problems, identify root causes, and propose effective solutions within a systems engineering context.
Critical Thinking: Ability to evaluate information critically, anticipate potential issues, and make sound, data-driven decisions.
Collaboration & Interpersonal: Proven ability to build strong working relationships, collaborate effectively with diverse teams (R&D, QA, Clinical, Product), and foster a positive, supportive team environment.
Attention to Detail: Meticulous attention to detail in documenting requirements, specifications, and analyses to ensure accuracy and compliance.
Systems Thinking: Ability to view problems in terms of interconnected systems, understanding how changes in one part affect the whole product lifecycle.
Essential Experience
Extensive experience (5-8+ years of progressive experience) in systems engineering, clinical engineering, or a related field within the medical device industry.
Proven experience in requirements management for medical devices throughout the product lifecycle (e.g., adherence to IEC 62304, IEC 60601, ISO 14971).
Deep understanding of the medical device design control process (e.g., FDA 21 CFR Part 820, ISO 13485) from concept to post-market.
Experience in analyzing and understanding complex clinical workflows and translating them into technical requirements.
Familiarity with medical device risk management principles and standards (e.g., ISO 14971).
Experience contributing to or leading verification and validation activities for complex systems.
Demonstrated experience working effectively in cross-functional teams and managing stakeholder expectations.
Experience with requirements management software (e.g., JIRA, DOORS, Polarion, Helix ALM) is preferred, or demonstrated ability to quickly adapt to and utilize alternative solutions.
Essential Educational Background
Bachelor's or Master's degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, or a closely related technical field.
What we offer
The opportunity to join a forward-thinking company with a collaborative team of innovative thinkers.
A rewarding career path with diverse opportunities for professional growth and development.
A competitive compensation and benefits package, including employer-paid health and dental benefits for eligible employees.
A generous learning and development budget for conferences, classes, and other professional development events.
