Systems Engineering Developer (2 Openings)

Intellijoint Surgical Inc; Kitchener; On-site; CAD 65,000 - 80,000; Full time

Benefits offered by this job

RRSP with employer match

Health/dental/vision package

Wellness benefit

Learning & development opportunities

Paid vacation & personal days

Job summary

Intellijoint Surgical is hiring two Systems Engineering Developers to join our growing Engineering team. Both roles help ensure our systems are designed, tested, validated, and documented to meet user needs, regulatory requirements, and internal quality standards.

One role supports commercially released Intellijoint Surgical products, while the other supports IJX innovation and prototyping initiatives. If you enjoy technical challenges and contributing to medical device development, this is an

Qualifications

• 3-5 years of relevant experience, including co-op or internship.
• Experience with software and hardware medical device systems.
• Familiarity with ISO 13485 and regulatory design controls.

Responsibilities

• Design and develop system-level solutions meeting user, product, and business requirements.
• Create and maintain software and system design specifications with development teams.
• Lead system design reviews with cross-functional stakeholders.
• Plan, design, and execute verification and validation activities with surgeons and stakeholders.
• Maintain traceability between requirements, risks, and verification activities.

Skills

Medical device software

Regulated environment

System design

Technical writing

Education

Bachelor’s degree in CS/Software/BME

Tools

IEC 62304

ISO 14971

Job description

Type of Position: Full-Time – 2 Positions

Location: Kitchener, ON – In office 4-days a week

Benefits: 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

Salary Range: $65k - $80k *Individual placement within the salary range will be based on experience, skills, market data, and internal equity considerations*

The Company

Intellijoint Surgical develops effective, easy-to-use technologies that enhance surgeons’ care and improve patients’ lives. Our technology supports surgeons in the operating room during hip and knee replacement procedures, helping improve surgical outcomes and providing valuable real-world data that informs future innovation.

Within Intellijoint Surgical is IJX, a business unit focused on commercializing navigation and planning technologies through innovative business models across clinical applications.

The Positions

We are hiring 2 Systems Engineering Developers to join our growing Engineering team. Both roles help ensure our systems are designed, tested, validated, and documented to meet user needs, regulatory requirements, and internal quality standards. The key difference between the roles is focus: one role supports commercially released Intellijoint Surgical products, while the other supports IJX innovation and prototyping initiatives.

Whether your passion lies in bringing new ideas to life, or advancing established products used by surgeons every day, this is an opportunity to make a meaningful impact on patient care!

These roles are ideal for someone who:

• Has strong engineering foundations and experience in medical device development within a regulated environment (ISO 13485).
• Understands complex software and hardware systems and can specify, verify, validate and document them with precision.
• Enjoys collaborating and solving challenging technical problems across engineering, quality, regulatory, clinical, and business teams.
• Is process-oriented, detail-focused, and comfortable with documentation, traceability, and risk management.
• Is energized by either early-stage prototyping and innovation or solving complex challenges for commercialized products.

What You Will Do:

Systems Design & Engineering

• 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.

Role Specific Focus: IJS

• Investigate and resolve technical issues identified through field feedback, manufacturing, quality, or supply chain activities.
• Develop and implement design changes that improve product performance, reliability, manufacturability, or usability.

Role Specific Focus: IJX

• Prototype system-level concepts, including software, algorithms, and mechanical instrumentation.
• Evaluate emerging technologies and contribute to the development of innovative products and clinical applications.
• Contribute to advanced algorithm development and testing in areas such as computer vision, medical imaging processing, machine learning, and 3D registration.

Verification & Validation

• 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.

Design Controls & Documentation

• 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.

Skills and Experience to Enable Success:

• 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.

Assets:

• 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.

Why Join Us?

• 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 [e-mail]. Any information received that relates to accommodation needs of a candidate will be addressed in a confidential manner.