Systems Risk Engineer (Hybrid)

Kardium; Burnaby; On-site; CAD 94,000 - 120,000; Full time

Job summary

A medical device company in Burnaby seeks a Quality Engineer to support software and electrical product design through risk management. The ideal candidate has a degree in Engineering, at least 4 years in design, and 3 years in a regulated industry. Join a diverse team aiming to enhance patient care with innovative solutions. Competitive compensation includes a salary of CAD 94,000 - 120,000 and comprehensive benefits.

Benefits

Comprehensive medical & dental coverage

Work-day flexibility

Support for family building

Career progression and learning support

Professional membership support

Qualifications

• 4 years of experience in software architecture design or electrical system design.
• 3 years in a regulated industry, preferably in medical devices.
• Knowledge of risk management processes (e.g., ISO 14971, ISO 60601).
• Experience with medical device cybersecurity methodologies.
• Understanding of GDPR and information security standards.

Responsibilities

• Support and influence software and electrical product design through risk management.
• Analyze and document safety risks in software and electrical systems.
• Contribute to software and electrical test and verification protocols.
• Perform impact analysis of design changes on safety and cybersecurity.

Skills

Analytical skills

Attention to detail

Communication skills

Interpersonal skills

Education

Bachelor's or higher degree in Software Engineering, Electrical Engineering or Computer Science

Tools

Risk management tools (Failure Mode and Effect Analysis, Hazard Analysis)

Job description

Your Opportunity

By joining the Kardium team you can help make a difference in the lives of millions around the world. Kardium is developing a groundbreaking medical device for the minimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure and other heart-related complications.

You will be an integral part of the Quality Engineering team but collaborating intensively with the Software Development and Testing, and Electrical Engineering teams. Your daily activities will center around supporting and influencing software and electrical product design and development through system-level risk management activities. Critical to the success of this function are strong analytical skills and your high attention to detail and rigor in software and electrical design analysis and ensuring all regulatory standards are met.

What you\'ll be doing...

• Work closely with the Software Development team to understand product software architecture and design in-depth and analyze and document safety. Provide guidance to the Software team in design and development of safety and cyber-security risks mitigation by contributing to Software requirements, architecture, and interface design.
• Work closely with the Electrical Design team to understand product design in-depth, and analyze and document safety risks.
• Contribute to development and implementation of software and electrical test and verification protocols.
• Perform impact analysis of software and electrical design changes and new features on the safety and security risk profile of the device.
• Perform impact analysis of system design changes and new features on the risk profile of the device in accordance with ISO 60601.
• Analyze software bugs for impact on the safety and cybersecurity profile of the device.
• Develop the cybersecurity threat models and recommend security mitigations.

What you bring to the team...

Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people\'s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable. You bring to the team these characteristics, plus :

• Minimum Bachelor\'s or higher degree in Software Engineering, Electrical Engineering or Computer Science with minimum of 4 years of experience in conducting software architecture design, electrical system design, or a combination of both.
• Minimum of 3 years\' experience in a regulated industry, preferably in medical devices or biotechnology.
• Working knowledge of risk management process (e.g., ISO 14971, ISO 60601) and hands-on experience with risk management tools (Failure Mode and Effect Analysis, Hazard Analysis, etc.)
• Experience with medical device cybersecurity methodologies
• Knowledge of information security standards (e.g., GDPR).
• Excellent written & verbal communication and technical documentation skills.
• Strong analytical and interpersonal skills.
• Excellent ability to come up to speed quickly on complex subject matter across multiple disciplines.

Compensation

Kardium has listed the total cash compensation range (base salary + 5% RRSP contribution) that we expect to pay applicants for this role, as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted.

As a permanent employee, you will also participate in Kardium\'s stock option plan.

• 94,000 - 120,000 (CAD Annually)

Your Benefits & Well-being

The total cash we\'ve listed for this position includes a base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals.

Comprehensive medical & dental coverage for all permanent employees - effective as of Day 1, with no waiting period.

Work-day flexibility - additionally, we provide 3 personal days per year.

Support for you (and your dependents) overall well-being.

Family building - we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.

Career progression and learning support.

Professional membership support.

Life at Kardium

What makes us a great place to work?

• Our Purpose
• Our People
• Our Culture

At Kardium, we embrace diversity of background, experience, and perspective and we\'re committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities.

We collaborate with Employee Resource Groups (ERGs), as volunteer-led groups who share a common dimension of diversity and come together to provide support, education, and other opportunities across Kardium. Examples of our ERGs include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, and Irish ERG.

As part of your application, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team.

And our employees think we are great too - check out Glassdoor to learn more!