Systems Engineering Developer (2 Openings)

Intellijoint Surgical•Kitchener, ON

3d•CA$65,000 - CA$80,000•Hybrid

About The Position

Intellijoint Surgical is seeking two Systems Engineering Developers to join their growing Engineering team. These roles are crucial for ensuring that their systems are designed, tested, validated, and documented to meet user needs, regulatory requirements, and internal quality standards. One role will focus on commercially released Intellijoint Surgical products, while the other will support IJX innovation and prototyping initiatives. This is an opportunity to make a meaningful impact on patient care by either bringing new ideas to life or advancing established products used by surgeons daily.

Requirements

Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related field.
3-5 years of relevant experience, including applicable co-op or internship experience.
Experience working with software and hardware medical device systems.
Strong familiarity with regulated environments, including ISO 13485 requirements, verification, validation and traceability activities.
Experience with risk management processes under ISO 14971.
Understanding of the medical device development lifecycle and how regulatory requirements influence system design.
Strong technical writing skills and exceptional attention to detail.
Familiarity with software and hardware development concepts, architectures, and lifecycle processes.
Experience with IEC 62304, IEC 62366, and ISO 27001 or similar frameworks.
Experience planning and conducting usability studies and validation activities.
Interest in emerging technologies and solving complex technical challenges.

Nice To Haves

Experience with surgical navigation, robotics, imaging, planning, or other advanced medical technologies.
Experience developing or evaluating algorithms related to computer vision, machine learning, image processing, or 3D spatial systems.

Responsibilities

Design and develop system-level solutions that meet user, product, and business requirements.
Create and maintain software and system design specifications in collaboration with development teams.
Lead and participate in system design reviews with cross-functional stakeholders.
Balance quality, cost, risk, usability, and time-to-market considerations in design decisions.
Investigate and resolve technical issues identified through field feedback, manufacturing, quality, or supply chain activities (IJS role focus).
Develop and implement design changes that improve product performance, reliability, manufacturability, or usability (IJS role focus).
Prototype system-level concepts, including software, algorithms, and mechanical instrumentation (IJX role focus).
Evaluate emerging technologies and contribute to the development of innovative products and clinical applications (IJX role focus).
Contribute to advanced algorithm development and testing in areas such as computer vision, medical imaging processing, machine learning, and 3D registration (IJX role focus).
Plan, design, develop and execute system-level verification and validation activities.
Plan, conduct, and report on formative and summative validation activities with surgeons, business stakeholders, and other end users.
Document results in engineering reports and formal test documentation.
Maintain traceability between requirements, risks, and verification activities throughout the product lifecycle.
Manage design inputs and outputs, including requirements, specifications, risk management files, and V&V documentation within the Design History File (DHF).
Drive risk management activities, including hazard analysis, risk assessment, and mitigation strategies.
Support patient safety, cybersecurity, and privacy requirements within system designs.
Contribute to Product Instructions for Use (IFU) and related technical documentation.
Ensure compliance with Intellijoint’s Quality Management System (QMS) and participate in continuous improvement initiatives.