Title: System Designer
Duration: 6 Months
Location: Montreal, QC H3C 2N6
 
Job Description:

• The ideal candidate will have a solid background in system design and product development, with direct experience in regulatory compliance and documentation.
• You'll play a key role in refining existing product documentation and ensuring continued regulatory alignment as part of an accelerated product remediation and continuous improvement initiative.
• This role is part of a cross-functional design and service transfer project focused on improving the serviceability and reliability of robotic-assisted surgical systems. The project involves:

1. Updating Design History File (DHF) documentation
2. Defining servicing design inputs
3. Creating job cards and spare part technical specifications
4. Supporting servicing verification and validation activities

• The candidate will work closely with R&D, Service Engineering, Quality, Operations, and Field Service teams to ensure design outputs are properly translated into production and servicing specifications in compliance with applicable regulatory frameworks.
• The work is delivered in an agile environment with iterative planning cycles, backlog grooming, and regular cross-functional alignment.
• Candidates must have experience with:

1. Software as a Medical Device (SaMD) concepts
2. Robotic or electromechanical medical device platforms

Skills Requirements:

• 5+ years of experience in system design and/or product development within the medical device industry
• Strong experience in system design in a multidisciplinary organization, preferably involving robotic or electromechanical medical devices
• Experience drafting and maintaining DHF (Design History File) content, including:
  • User needs
  • System requirements
  • Design inputs
  • Traceability matrices
  • Risk documentation
• Ability to define servicing design inputs and translate them into:
  • Job cards
  • Spare part replacement procedures
  • Planned maintenance instructions
  • Troubleshooting guides
  • Installation instructions
  • Spare part technical specifications
• Experience with design transfer and/or service transfer processes
• Ability to support risk analysis (uFMEA, etc.) and usability planning
• Familiarity with ISO 14971 (required)
• Familiarity with IEC 62366 (preferred)
• Ability to define testable requirements and support V&V protocol development
• Experience with traceability management

Additional Requirements:

• Reliability analysis experience, including:
  • Mean Time to Failure (MTTF)
  • Impact analysis for serviceable components
  • Worst-case servicing condition validation
• Knowledge of:
  • 21 CFR 820 (Quality System Regulation)
  • ISO 13485
  • EU MDR
  • FDA guidance on remanufacturing/refurbishment of medical devices
• Strong interpersonal and collaboration skills
• Ability to build consensus across cross-functional teams
• Ability to communicate technical concepts to both technical and non-technical audiences
• Experience identifying and resolving cross-team dependencies
• Hands-on Agile or hybrid Agile experience:
  • Sprint planning
  • Backlog grooming
  • Daily standups
  • Retrospectives
• Experience with:
  • Codebeamer and/or JIRA
  • Requirements management
  • Traceability tools
• Experience working in highly regulated environments
• CAPA-driven improvement project experience
• Strong analytical and decision-making skills
• Experience working in multi-site, cross-functional organizations
• Excellent written and verbal communication skills

Preferred Qualifications:

• Experience with SSRS (System Service Specification Requirements) creation and verification
• Familiarity with lifecycle testing methodologies for serviceable components and systems
• Experience supporting spare parts forecasting, demand planning, or BOM management
• Understanding of Field Change Order (FCO) processes
• Experience with ServiceMax or similar field service management platforms
• Experience with refurbishment or redeployment programs for capital medical equipment
• Certified Scrum Master (CSM), SAFe Agilist, or equivalent Agile certification
• Experience facilitating cross-functional workshops, design reviews, or sprint demos in regulated environments

Education Requirements:

• Bachelor's degree in an engineering or science-related field
• Preferred disciplines:
  • Biomedical Engineering
  • Mechanical Engineering
  • Systems Engineering

 
  
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 62.49/hr.