06 Sep
|
Intellijoint Surgical
|
Kitchener
06 Sep
Intellijoint Surgical
Kitchener
Direct message the job poster from Intellijoint Surgical Inc.
Talent Business
Partner at Intellijoint Surgical Inc.
Full-Time Kitchener, ON – In office 4-days a week and 1-day remote RRSP with employer match, health/dental/vision package (day-1 and employer-paid premiums!), wellness benefit, learning & development opportunities, paid vacation, personal days and sick days Today, Intellijoint technology lives in the operating room, helping surgeons improve implant positioning during hip and knee replacement surgeries.
Systems Engineering
Developer to join our R&D; team to help bring innovative technologies to the market.
Systems Engineering
Developer will help ensure our systems are designed, tested, and validated to meet user needs, regulatory expectations, and internal quality standards. 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 Systems Design and Engineering: 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 coordinate with the development team (e.g. refining user stories) Ensure designs and solutions balance quality, cost, and time‑to‑market. 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.
Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related field.
Experience working with medical devices (hardware and software).
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. IEC 62304 (Software), IEC 62366 (Usability), and ISO 27001 (Privacy/Security). Interest in researching emerging medical technologies.
Work on innovative products that improve surgical outcomes and enhance patient’s quality of life Work in an environment with high transparency and collaboration along with lots of fun and social activities It is our policy to recruit and select applicants solely on the basis of their qualifications. We are an equal prospect 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. Those in need of accommodation at any stage in the recruitment process should notify hr@intellijointsurgical.
📌 Systems Engineering Developer (Kitchener)
🏢 Intellijoint Surgical
📍 Kitchener