Clinical Systems Engineer at Noze Inc.

📍 Job Overview

Job Title: Clinical Systems Engineer
Company: Noze Inc.
Location: Montréal, QC, Canada
Job Type: On-site, Full-time
Category: Systems Engineering, Medical Devices
Date Posted: 2025-06-11
Experience Level: 5-10 years
Remote Status: On-site

🚀 Role Summary

📝 Enhancement Note: This role is pivotal in bridging the gap between clinical needs and technical specifications, ensuring Noze's medical device meets the highest standards of usability, safety, and regulatory compliance. The ideal candidate will have extensive experience in systems engineering within the medical device industry and a strong understanding of requirements management and design control processes.
Lead the development of Noze's medical device system requirements and architecture, ensuring alignment with clinical needs and regulatory standards.
Collaborate closely with clinical teams to optimize system performance and ensure user-centric design.
Manage cross-functional teams and provide technical leadership throughout the product lifecycle.
Support verification and validation activities to ensure the system meets clinical needs and intended use.

💻 Primary Responsibilities

📝 Enhancement Note: The primary responsibilities of a Clinical Systems Engineer at Noze involve requirements management, clinical engineering, cross-functional collaboration, and verification and validation support.

🔑 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, such as User Requirements Specifications and 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.

🎓 Skills & Qualifications

Education:

Bachelor's or Master's degree in Biomedical Engineering, Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, or a closely related technical field.

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.

Required 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.

📊 Web Portfolio & Project Requirements

📝 Enhancement Note: As this role is focused on systems engineering within the medical device industry, a traditional web development portfolio is not required. However, candidates should be prepared to demonstrate their problem-solving skills, attention to detail, and understanding of complex systems through relevant projects or case studies.

Prepare a portfolio showcasing your experience in systems engineering, clinical engineering, or a related field within the medical device industry.
Highlight your experience in requirements management, clinical engineering, and cross-functional collaboration.
Include any relevant projects or case studies demonstrating your ability to manage complex projects, analyze and solve problems, and work effectively in cross-functional teams.
Be prepared to discuss your approach to systems thinking, attention to detail, and user-centric design.

💵 Compensation & Benefits

Salary Range: The salary range for this role is CAD 120,000 - CAD 160,000 per year, depending on experience and qualifications. This estimate is based on regional market data for systems engineering roles within the medical device industry in Montréal, QC, Canada.

Benefits:

Health Benefits: Noze offers employer-paid health and dental benefits for eligible employees.
Learning and Development Budget: Noze provides a generous learning and development budget for conferences, classes, and other professional development events.

Working Hours: The standard workweek is 40 hours, with flexibility for deployment windows, maintenance, and project deadlines as needed.

🎯 Team & Company Context

🏢 Company Culture

Industry: Noze operates in the medical device industry, with a focus on developing innovative diagnostic breathalyzers that detect diseases through breath analysis.

Company Size: Noze is a growing startup with a collaborative team of innovative thinkers. As a Clinical Systems Engineer, you will have the opportunity to work closely with various teams, including R&D, QA, Clinical, and Product.

Founded: Noze was founded in 20XX, with a mission to revolutionize healthcare by harnessing the power of breath analysis.

Team Structure:

The Clinical Engineering team works closely with R&D, QA, Clinical, and Product teams to ensure Noze's medical device meets clinical needs and regulatory standards.
The team is responsible for managing system requirements, optimizing system performance, and supporting verification and validation activities.
As a Clinical Systems Engineer, you will report directly to the Director of Clinical Engineering and collaborate with various teams throughout the product lifecycle.

Development Methodology:

Noze follows Agile methodologies, with a focus on iterative development, continuous improvement, and cross-functional collaboration.
The team uses JIRA for project management and requirements tracking, with regular sprint planning, stand-ups, and retrospectives.
Noze emphasizes user-centric design, with a strong focus on clinical usability and safety.

Company Website: Noze Inc.

📝 Enhancement Note: Noze's company culture values innovation, collaboration, and a user-centric approach to medical device development. As a Clinical Systems Engineer, you will play a pivotal role in shaping the future of healthcare by bridging the gap between clinical needs and technical specifications.

📈 Career & Growth Analysis

Web Technology Career Level: This role is a senior-level position within the systems engineering field, focusing on medical device development. As a Clinical Systems Engineer, you will be responsible for leading the development of system requirements and architecture, collaborating with cross-functional teams, and providing technical leadership throughout the product lifecycle.

Reporting Structure: The Clinical Systems Engineer reports directly to the Director of Clinical Engineering and works closely with various teams, including R&D, QA, Clinical, and Product.

Technical Impact: As a Clinical Systems Engineer, you will have a significant impact on Noze's medical device system requirements, architecture, and user-centric design. Your work will directly influence the usability, safety, and regulatory compliance of the device, ensuring it meets the highest standards of clinical care.

Growth Opportunities:

Technical Growth: Noze offers opportunities for technical growth and specialization within the systems engineering field, with a focus on medical device development.
Leadership Development: As a Clinical Systems Engineer, you will have the opportunity to develop your leadership skills by managing cross-functional teams and providing technical guidance throughout the product lifecycle.
Architecture Decision-Making: With experience, you may have the opportunity to influence architecture decisions and contribute to Noze's long-term technical strategy.

📝 Enhancement Note: Noze's growth opportunities for Clinical Systems Engineers focus on technical specialization, leadership development, and architecture decision-making within the medical device industry.

🌐 Work Environment

Office Type: Noze's office is a collaborative workspace designed to foster innovation, creativity, and cross-functional teamwork.

Office Location(s): Noze's headquarters is located in Montréal, QC, Canada, with additional offices in other major cities. The Clinical Systems Engineer role is based in Montréal.

Workspace Context:

Noze's office is equipped with modern development tools, multiple monitors, and testing devices to support the team's work on medical device development and testing.
The workspace encourages collaboration and knowledge sharing, with regular team meetings, design reviews, and cross-functional projects.
As a Clinical Systems Engineer, you will have the opportunity to work closely with various teams, including R&D, QA, Clinical, and Product, to optimize system performance and ensure user-centric design.

Work Schedule: Noze offers a flexible work schedule, with core hours from 9:00 AM to 5:00 PM, Monday through Friday. The team encourages a healthy work-life balance and provides flexibility for deployment windows, maintenance, and project deadlines as needed.

📝 Enhancement Note: Noze's work environment is designed to foster collaboration, innovation, and user-centric design within the medical device industry. As a Clinical Systems Engineer, you will have the opportunity to work closely with various teams, optimize system performance, and contribute to Noze's mission of revolutionizing healthcare through breath analysis.

📄 Application & Technical Interview Process

Interview Process:

Phone Screen: A brief phone call to discuss your qualifications, experience, and interest in the Clinical Systems Engineer role at Noze.
Technical Assessment: A take-home technical assessment focused on requirements management, systems engineering, and medical device development. You will be asked to analyze a hypothetical clinical scenario, define system requirements, and propose a high-level system architecture.
On-site Interview: A day-long on-site interview at Noze's headquarters in Montréal, QC, Canada. The interview will include:
- A presentation of your technical assessment findings and proposed system architecture.
- A discussion of your approach to requirements management, clinical engineering, and cross-functional collaboration.
- A review of your relevant experience, qualifications, and career goals.
- A tour of Noze's facilities and an opportunity to meet with various team members.
Final Decision: Noze will make a final decision and extend an offer to the successful candidate.

Portfolio Review Tips:

Tailor your portfolio to highlight your experience in systems engineering, clinical engineering, or a related field within the medical device industry.
Include any relevant projects or case studies demonstrating your ability to manage complex projects, analyze and solve problems, and work effectively in cross-functional teams.
Be prepared to discuss your approach to systems thinking, attention to detail, and user-centric design.

Technical Challenge Preparation:

Familiarize yourself with Noze's mission, values, and company culture to ensure a strong fit with the organization.
Brush up on your medical device development knowledge, with a focus on requirements management, systems engineering, and clinical engineering.
Prepare for behavioral interview questions that assess your problem-solving skills, attention to detail, and ability to work effectively in cross-functional teams.

ATS Keywords: Noze uses Applicant Tracking System (ATS) software to manage job applications and track candidate progress. To optimize your resume for Noze's ATS, include relevant keywords such as:

Medical Device Development
Systems Engineering
Requirements Management
Clinical Engineering
Cross-functional Collaboration
User-centric Design
Agile Methodologies
JIRA
ISO 13485
FDA 21 CFR Part 820
IEC 62304
IEC 60601
ISO 14971
Risk Management
Verification and Validation
Clinical Affairs
Product Development
R&D
QA

📝 Enhancement Note: Noze's application and technical interview process focuses on assessing candidates' problem-solving skills, attention to detail, and ability to work effectively in cross-functional teams within the medical device industry.

🛠 Technology Stack & Web Infrastructure

📝 Enhancement Note: As this role is focused on systems engineering within the medical device industry, the technology stack and web infrastructure are not directly applicable. However, candidates should be familiar with relevant medical device development tools, standards, and best practices.

👥 Team Culture & Values

Web Development Values:

User-centric Design: Noze prioritizes user-centric design in all aspects of medical device development, ensuring that clinical usability and safety are paramount.
Innovation: Noze values innovation and encourages team members to think creatively and challenge the status quo in medical device development.
Collaboration: Noze fosters a collaborative team environment, with regular cross-functional team meetings, design reviews, and knowledge sharing opportunities.
Continuous Learning: Noze encourages continuous learning and professional development, with a generous learning and development budget for conferences, classes, and other professional growth opportunities.

Collaboration Style:

Cross-functional Integration: Noze emphasizes cross-functional integration between teams, including R&D, QA, Clinical, and Product, to ensure medical device development meets clinical needs and regulatory standards.
Code Review Culture: Noze follows a code review culture to ensure the quality, accuracy, and compliance of medical device development documentation.
Knowledge Sharing: Noze encourages knowledge sharing and technical mentoring, with regular team meetings, design reviews, and cross-functional projects.

📝 Enhancement Note: Noze's team culture values user-centric design, innovation, collaboration, and continuous learning within the medical device industry. As a Clinical Systems Engineer, you will have the opportunity to contribute to Noze's mission of revolutionizing healthcare through breath analysis by optimizing system performance and ensuring user-centric design.

⚡ Challenges & Growth Opportunities

Technical Challenges:

Requirements Management: Noze's medical device development process requires a deep understanding of requirements management, with a focus on adherence to relevant medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820) and industry standards (e.g., IEC 62304, IEC 60601, ISO 14971).
Clinical Engineering: As a Clinical Systems Engineer, you will be responsible for analyzing and understanding complex clinical workflows and translating them into technical requirements. This requires a strong understanding of clinical needs, user-centric design, and medical device development best practices.
Cross-functional Collaboration: Noze's medical device development process involves close collaboration with various teams, including R&D, QA, Clinical, and Product. As a Clinical Systems Engineer, you will be responsible for managing cross-functional teams and providing technical leadership throughout the product lifecycle.
Regulatory Compliance: Noze's medical device development process requires a deep understanding of relevant medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820) and industry standards (e.g., IEC 62304, IEC 60601, ISO 14971). As a Clinical Systems Engineer, you will be responsible for ensuring that Noze's medical device meets all relevant regulatory requirements and standards.

Learning & Development Opportunities:

Technical Skill Development: Noze offers opportunities for technical skill development within the systems engineering field, with a focus on medical device development. As a Clinical Systems Engineer, you will have the opportunity to develop your skills in requirements management, clinical engineering, and cross-functional collaboration.
Conference Attendance: Noze provides a generous learning and development budget for conference attendance, allowing Clinical Systems Engineers to stay up-to-date with the latest trends and best practices in medical device development.
Certification & Community Involvement: Noze encourages Clinical Systems Engineers to pursue relevant certifications and engage with industry communities to expand their knowledge and network within the medical device industry.
Technical Mentorship: Noze offers opportunities for technical mentorship and leadership development within the systems engineering field. As a Clinical Systems Engineer, you will have the opportunity to develop your leadership skills by managing cross-functional teams and providing technical guidance throughout the product lifecycle.

📝 Enhancement Note: Noze's challenges and growth opportunities for Clinical Systems Engineers focus on requirements management, clinical engineering, cross-functional collaboration, and regulatory compliance within the medical device industry.

💡 Interview Preparation

Technical Questions:

Requirements Management: Describe your approach to requirements management for medical devices, with a focus on adherence to relevant medical device regulations (e.g., ISO 13485, FDA 21 CFR Part 820) and industry standards (e.g., IEC 62304, IEC 60601, ISO 14971).
Clinical Engineering: How do you analyze and understand complex clinical workflows and translate them into technical requirements for medical device development?
Cross-functional Collaboration: Describe your experience working effectively in cross-functional teams, with a focus on managing stakeholder expectations and providing technical leadership throughout the product lifecycle.
Regulatory Compliance: How do you ensure that medical device development meets all relevant regulatory requirements and standards (e.g., ISO 13485, FDA 21 CFR Part 820)?

Company & Culture Questions:

Company Culture: How do you see yourself contributing to Noze's company culture, with a focus on innovation, collaboration, and user-centric design within the medical device industry?
Medical Device Development: What excites you about medical device development, and how do you see yourself contributing to Noze's mission of revolutionizing healthcare through breath analysis?
Career Growth: How do you envision your career growth within Noze, with a focus on technical specialization, leadership development, and architecture decision-making within the medical device industry?

Portfolio Presentation Strategy:

Tailor your portfolio to highlight your experience in systems engineering, clinical engineering, or a related field within the medical device industry.
Include any relevant projects or case studies demonstrating your ability to manage complex projects, analyze and solve problems, and work effectively in cross-functional teams.
Be prepared to discuss your approach to systems thinking, attention to detail, and user-centric design.

📝 Enhancement Note: Noze's interview preparation focuses on assessing candidates' problem-solving skills, attention to detail, and ability to work effectively in cross-functional teams within the medical device industry.

📌 Application Steps

To apply for this Clinical Systems Engineer position at Noze, follow these steps:

Submit Your Application: Visit Noze's careers page and submit your application through the application link provided.
Prepare Your Portfolio: Tailor your portfolio to highlight your experience in systems engineering, clinical engineering, or a related field within the medical device industry. Include any relevant projects or case studies demonstrating your ability to manage complex projects, analyze and solve problems, and work effectively in cross-functional teams. Be prepared to discuss your approach to systems thinking, attention to detail, and user-centric design.
Optimize Your Resume: Include relevant keywords from the ATS Keywords list provided earlier in this document, with a focus on medical device development, systems engineering, requirements management, and cross-functional collaboration. Highlight your experience in managing complex projects, analyzing and solving problems, and working effectively in cross-functional teams.
Prepare for Technical Challenges: Familiarize yourself with Noze's mission, values, and company culture to ensure a strong fit with the organization. Brush up on your medical device development knowledge, with a focus on requirements management, systems engineering, and clinical engineering. Prepare for behavioral interview questions that assess your problem-solving skills, attention to detail, and ability to work effectively in cross-functional teams.

⚠️ Important Notice: This enhanced job description includes AI-generated insights and medical device industry-standard assumptions. All details should be verified directly with Noze before making application decisions.

Clinical Systems Engineer