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Systems Designer

Iconma

Montreal, QC

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JOB DETAILS
SALARY
$31.99–$34.40 Per Hour
SKILLS
Analysis Skills, Atlassian JIRA, Clinical Information Systems, Clinical Practices/Protocols, Communication Skills, Cross-Functional, Documentation, FDA (Food and Drug Administration), File Maintenance, Health Plan, Healthcare, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Internet Security, Maintain Compliance, Medical Equipment, Performance Testing, Product Design, Product Development, Product Requirements Document (PRD), Product Reviews, Product Testing, Quality Assurance, Quality Assurance Methodology, Regulations, Regulatory Compliance, Requirements Management, Research & Development (R&D), Risk, Risk Analysis, Risk Management, Sustainability, System Test, Team Player, Technical/Engineering Design, Test Automation, Test Plan/Schedule, Testing, Traceability, Usability Engineering, V&V Testing, Validation Testing
LOCATION
Montreal, QC
POSTED
1 day ago
Our Client, a Medical Devices/Healthcare company, is looking for a Systems Designer for their Montreal, QC/Remote location.
 
Responsibilities:
System Design
  • Define the design approach, ensuring alignment with product objectives, user needs, clinical workflows, and system performance.
  • Translate user needs and system requirements into practical design solutions.
  • Lead design discussions and technical reviews, evaluating alternatives and trade-offs.
  • Ensure design decisions address usability, risk mitigation, technical feasibility, and long-term product sustainability.
System Testing
  • Implement and review product verification and validation (V&V) testing, including developing protocols, test methods, and performance specifications.
  • Perform manual and automated testing and document results accurately.
Product Documentation
  • Collaborate with QA, Service, Compliance, and Regulatory teams to meet documentation requirements and ensure cross-functional alignment.
  • Create, review, and maintain risk management files, including cybersecurity risks.
  • Ensure all product requirements are documented, traceable to verifiable tests, and kept up-to-date.
  • Ensure compliance with FDA, ISO, and internal design controls.
  • Maintain the Design History File (DHF) to be complete, accurate, and regulatory-compliant, addressing gaps proactively.
 
Requirements:
  • The ideal candidate will have a solid background in medical device design controls and product development, with direct experience in regulatory compliance and documentation.
  • You’ll play a key role in refining existing documentation and ensuring continued regulatory alignment to support new and existing products.
  • Candidates must have experience with software as a medical device (SaMD).
  • 5+ years of experience
  • Strong Experience with Software as a Medical Device (SaMD)
  • Strong experience in design controls in a multi-disciplinary organization.
  • Experience drafting and maintaining DHF (design history file) content, including user needs, design inputs, design outputs, traceability matrices, and risk documentation.
  • Able to support risk analysis (e.g. uFMEA, etc.) and contribute to usability planning and design mitigations.
  • Familiarity with ISO 14971 is required, and IEC 62366 preferred.
  • Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team.
  • Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.
  • Must have experience in a regulatory environment with strict compliance.
  • Strong analytical skills and accurate judgment-making skills.
  • Ability to deal effectively with internal and external collaborators.
  • Excellent communications skills; written and verbal.
  • Experience with Codebeamer, Jira, or similar.
  • Bachelor’s degree in engineering or science related field; biomedical engineering preferred.
 
Why Should You Apply?  
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive considerationfor employment without regard to any status protected by applicable law.

About the Company

I

Iconma

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

  • Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
  • Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
  • Founded in 2000
  • 2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Management Consulting Services
EMPLOYEE BENEFITS
401K, Employee Referral Program, Life Insurance
FOUNDED
2000
WEBSITE
https://www.iconma.com/

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