The Position

As part of the R&D team at Intellijoint Surgical, the Systems Engineering Developer will help ensure our systems are designed, tested, and validated to meet user needs, regulatory expectations, and internal quality standards.

This role is ideal for someone who:

• Has strong engineering foundations and experience in medical device (ISO 13485)
• Understands how software and hardware systems behave so you can verify, validate, and document them with precision.
• Is process-oriented, detail-obsessed, and comfortable navigating structured documentation, traceability matrices, and risk analysis for complex systems in a regulated environment
• Enjoys working with cross-functional teams, engaging with users, and ensuring the product is safe, compliant, and high-performing.

Main Duties:

Systems Design and Engineering:

• Develop solutions for design changes and new product introductions that meet user and business expectations and requirements.
• Investigate and provide technical problem solving to sustain existing products (e.g. when issues or feedback are presented from field usage or manufacturing and procurement challenges arise).
• Create software design specifications and coordinating with the development team (e.g. refining user stories)
• Lead and participate in system design reviews with cross-functional stakeholders.
• Ensure designs and solutions balance quality, cost, and time-to market.

Verification & Validation:

• Plan, design, develop, and execute system level Verification & Validation (V&V) activities.
• Plan, conduct, and report on formative and summative system validation activities with business stakeholders, surgeons and other end users (simulated settings, cadaver labs, field environments, etc.).
• Document results in engineering reports and formal test report documentation for each project or release cycle.
• Ensure traceability of verification activities to requirements and risks across the product lifecycle.

Design Controls and Documentation:

• Manage design inputs and outputs including requirements, risk management files, specification documents and V&V reports within the Design History File (DHF).
• Drive Risk Management process activities: conduct hazard analysis, assess risks, and determine mitigation strategies and designs for hardware and software maintaining both patient safety and privacy and cybersecurity.
• Contribute to the product Instructions for Use (IFU) and other technical supporting documentation packages.
• Ensure compliance with Intellijoint’s Quality Management System (QMS), execute current procedures and processes, identify areas for improvement and drive process changes in the QMS.

Skills and Experience to Enable Success:

• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related field.
• Experience working with medical devices (hardware and software).
• Strong familiarity with QMS environments (ISO 13485), regulated documentation, verification, and traceability requirements.
• Experience with risk management activities under ISO 14971.
• Understanding of the medical device product lifecycle and how requirements and regulations drive system design.
• Strong technical writing skills and exceptional attention to detail.
• Familiar with software and hardware development concepts (e.g. architecture, tech stacks, SDLC), sufficient to test and verify system behavior.
• Experience with ISO frameworks: IEC 62304 (Software), IEC 62366 (Usability), and ISO 27001 (Privacy/Security).
• Experience with conducting formative and summative usability validation.
• Interest in researching emerging medical technologies.

Why join us?

• It is unrealistic for us to believe we will find someone who fits this position 100% - interested? Apply!
• Strong support towards career development and growth
• Work on innovative products that improve surgical outcomes and enhance patient’s quality of life
• Work alongside a highly talented and driven group of team members and colleagues’ organization wide
• Work in an environment with high transparency and collaboration along with lots of fun and social activities
• Be ok with change and share in our excitement as we scale
• Flexibility so that you can do your best both at work and outside of it

Intellijoint Surgical is committed to creating an accessible and inclusive work environment. It is our policy to recruit and select applicants solely on the basis of their qualifications. We are an equal opportunity employer that hires talent regardless of age, race, creed, colour, religion, national origin, ancestry, marital status, sexual orientation, gender identity or expression, disability, or any other status or condition protected by applicable law.

Intellijoint Surgical encourages applications from all qualified candidates. Those in need of accommodation at any stage in the recruitment process should notify hr@intellijointsurgical.com. Any information received that relates to accommodation needs of a candidate will be addressed in a confidential manner.