Careers
Kardium is a technology pioneer developing devices to address cardiovascular diseases. The company was founded in 2007 by a team with a track record of excellence in medicine, business, and engineering. Focused on building a world-class, internationally dominant medical device company, we believe in having lots of fun while working hard. We hire top individuals who are strong team players and trust them to make the right decisions to achieve our goals.
We expect to grow significantly in size over the next several years and are always interested in hearing from intelligent, enthusiastic, hard-working, entrepreneurial people. Kardium offers a flexible work environment, a comprehensive salary and benefits program and the ability to participate in equity through a stock option plan.
If you would like to:• work in a start up and have experience in mechanical, software or medical engineering, medical trials, or product management, contact at us at jobs@kardium.com.
• receive an email update when new job openings are posted, send an email to jobs@kardium.com with the subject "Subscribe to new job postings"
Kardium is located in Vancouver, Canada. Vancouver, home of the 2010 Winter Olympic and Paralympic Games, is a vibrant and diverse urban center surrounded by abundant natural attractions. The city is internationally ranked as one of the ‘Best Places To Live’ by the Mercer Consulting Quality of Living Survey.
The positions we are currently seeking to fill are:
• Biomedical Engineer (Cardiovascular Devices)
• Senior Applications Programmer, Medical Device Software
• Senior Systems Programmer, Medical Device Software
Kardium is looking for a talented individual to lead our Quality Assurance (QA) department. The successful candidate will be responsible for building and maintaining our ISO 13485 quality system. The successful candidate will also be responsible for planning, organizing, and working with our regulatory consultants to prepare our worldwide regulatory submissions to obtain marketing approval for Class I, II, and III medical devices.
Areas of responsibilities for this position include:
Quality
• Maintaining and expanding the Kardium Quality System in compliance with ISO 13485 standards
• Writing and reviewing Standard Operating Procedures (SOPs), work instructions and specification forms
• Participating in a wide variety of device development teams, including design control, FMEA, and design and process validation
• Reviewing document change requests and labelling, including assessments of regulatory impact
• Participating in supplier qualification activities
• Communicating quality policy, metrics and trends
Regulatory
• Preparing and maintaining Investigational Device Exemptions (IDE), Pre-Market Approval (PMA) Applications, PMA supplements as needed for Class I, II and III medical devices
• Developing and maintaining international regulatory submissions for FDA, CE marking, Health Canada and other international countries
• Maintaining current regulatory knowledge of domestic and international regulations, guidelines, and standards and applying appropriate implementation strategies
• Ensuring the quality and accuracy of all submissions to health authorities
The successful candidate will have:
• Strong project management, problem-solving, and negotiating skills
• Ability to execute tasks with minimal instruction and guidance
• Skill at analyzing and summarizing data
• Ability to write clear, understandable technical documentation
• Extreme attention to detail
• Ability to manage and prioritize multiple projects
• A track record of being highly productive
• Strong drive to succeed
The successful candidate will preferably have:
• Participated in the implementation of an ISO-13485 quality system
• 4-year degree in a scientific or technical discipline; advanced degree helpful
• 3-5 years of quality experience in the biotechnology industry
• Strong working knowledge of medical devices regulations (FDA and EU) and terminologies
• Experience bringing a Class III device through a PMA process
To apply for this position, please email your resume to jobs@kardium.com with a subject line of
"Quality Manager".
Biomedical Engineer (Cardiovascular Devices)
Kardium is developing a revolutionary catheter-based therapy for treatment of atrial fibrillation, and is seeking an experienced Biomedical Engineer to fill an exciting position on the preclinical research team. The multidisciplinary project combines high-precision mechanical components with state-of-the-art electronics and software. The successful candidate will work with a dynamic, enthusiastic, and driven research and development team to bring a truly innovative and beneficial product to market.
The Biomedical Engineer will work collaboratively with engineering teams in the characterization, testing, design refinement, verification and validation of the atrial fibrillation treatment system. He/she will play a key role in the planning and execution of pre-clinical testing activities in-house and at outside facilities. Essential qualifications of the successful candidate include at least five years of cardiovascular device research and testing experience within the medical device industry, hands-on experience with design of experiments, test fixture design and fabrication, coordination of off-site testing, and very strong analytical skills.
Candidate profile:
• A solid background in biomedical engineering with industry R&D experience
• Experience with medical image segmentation, processing, and analysis
• Experience in Design of Experiments (DoE) and statistics
• Mechanical design background with hands-on experience in both laboratories and machine shops
• Superior math and physics skills
• Experience with SolidWorks, Matlab, and LabView
• The ability to coordinate activities within a multi-disciplinary team
• Familiarity with medical device regulatory affairs and quality systems
Responsibilities:
• The design and execution of experiments serving to characterize, refine, and optimize device designs regarding device function and performance.
• Coordination and documentation of cadaver and in vivo device testing conducted off-site
• Acquisition and analysis of medical imaging datasets to build knowledge of heart chamber size and morphology
• Collaboration with mechanical, software, and electronics engineering teams to provide them with input and feedback on device designs
• Development of analytical tools to help interpret test results
• Work in the clinic to better understand user and therapeutic system requirements
To apply for this position, please email your resume to jobs@kardium.com with a subject line of "Biomedical Engineer (Cardiovascular Devices)".
Kardium is seeking an individual to fill a formative role in establishing the software test team for a next generation cardio-vascular medical device. We need someone who can come up to speed and start writing and executing test plans quickly. From there, the role can be further expanded to include creation of automated tests, customizing build scripts and ALM tools to enforce strict workflow and provide informative reports. Ultimately, there is potential for the successful candidate to assume leadership responsibilities when the team expands. This role is ideally suited to an experienced tester who has significant experience with scripting languages and is interested in expanding his/her programming skills and/or advancing towards a leadership role. Testing will focus on software but will likely extend to testing of associated hardware systems.
The software test lead will:
• Participate in wide variety of development efforts such as requirements reviews, design reviews, risk management and scheduling meetings/sessions.
• Witness live medical procedures to become familiar with medical terminology and the expected use of the product
• Write test plans as features are developed based on provided requirements and supplementary material
• Execute test plans, providing test reports, and creating detailed problem reports
• Modify build scripts to automate testing procedures
• Create automated tests to support frequent regression
• Customize tools to enforce workflow constraints
• Attend annual training for medical device verification and validation.
The successful candidate will have:
• At least 5 years of experience preparing and executing test plans for software
• Some experience with scripting languages such as Python and Perl
• Excellent writing, analytical and communication skills
• Good interpersonal and negotiating skills
• Ability to work under pressure and on multiple tasks, with demonstrated ability to meet deadlines
• Remain flexible and adaptable in order to take on extra challenges on a multi-disciplinary team
• Strong organizational skills
The successful candidate will preferably have:
• Computer Science, Engineering or Science degree
• Experience with Java, C/C++ and/or Ant
• Experience with testing medical device software or software in a regulated industry
To apply for this position, please email your resume to jobs@kardium.com with a subject line of "Medical Software Test Lead".
Senior Applications Programmer, Medical Device Software
Kardium is seeking an individual to work on our software applications for our Atrial Fibrillation solution. As a member of the software team you will develop software for new features including significant GUI development using a combination of Java Swing and Open GL facilities. Given input such as requirements, use cases, and mock-ups, the team member will design and implement the feature from the host GUI in Java down to the firmware in C. In addition you will participate in design reviews and code inspections with other team members.
Software in the medical device industry requires the highest quality standard in order to meet patient safety and regulatory requirements. This position will be best suited to an individual who tends towards quality over quantity. This position does not require the candidate to have any medical device experience and will provide an excellent opportunity to learn about the medical industry and writing medical software.
The candidate will:
• Implement new software features and modify existing ones for host PC and embedded software sub-systems
• Write automated unit tests and system-level regression tests
• Fix defects as identified by test personnel
• Participate in wide variety of development efforts such as requirements reviews, design reviews, risk management and scheduling meetings/sessions
• Witness live medical procedures to become familiar with medical terminology and the expected use of the product
• Attend annual training for medical device verification and validation
The successful candidate will have:
• At least 7 years of application development experience with an object-oriented language
• Excellent writing, analytical and communication skills
• The ability to quickly learn existing architecture and to design and code new features consistent with that architecture
• Good interpersonal and negotiating skills
• Ability to work under pressure and on multiple tasks, with demonstrated ability to meet deadlines
• Strong organizational skills
The successful candidate will preferably have:
• Computer Science, or Engineering degree
• Experience with specifically Java, C/C++
• Experience with embedded systems
• Experience with multi-threaded programs
• Experience with GUI development
To apply for this position, please email your resume to jobs@kardium.com with a subject line of "Senior Applications Programmer, Medical Device Software".
Senior Systems Programmer, Medical Device Software
Kardium is seeking an individual to work on our software systems for our Atrial Fibrillation solution. As a member of the software team you will work on non-GUI functionality improvements to both production and infrastructure code. The candidate will engage in improvements, optimizations, and algorithmic support for feature development. In addition you will participate in design reviews and code inspections with other team members. You will be tasked to work on several software systems including the production code, unit and automated regression tests, production utilities, build scripts, application life cycle management (ALM) system customizations and other tool development.
Software in the medical device industry requires the highest quality standard in order to meet patient safety and regulatory requirements. This position will be best suited to an individual who tends towards quality over quantity. This position does not require the candidate to have any medical device experience and will provide an excellent opportunity to learn about the medical industry and writing medical software.
The candidate will:
• Implement improvements, optimizations and support for new and existing software features for host PC and embedded software
• Implement unit tests for all code you develop to achieve high percentage code coverage
• Develop system-level regression test facilities
• Fix defects as identified by test personnel
• Create new and modify existing software process infrastructure such as build scripts, code generation scripts and tool customizations
• Participate in wide variety of development efforts such as requirements reviews, design reviews, risk management and scheduling meetings/sessions
• Witness live medical procedures to become familiar with medical terminology and the expected use of the product
• Attend annual training for medical device verification and validation
The successful candidate will have:
• At least 7 years of application development experience with an object-oriented language
• Some experience with scripting languages such as Python and Perl
• Excellent writing, analytical and communication skills
• Good interpersonal and communication skills
• Ability to work under pressure and on multiple tasks, with demonstrated ability to meet deadlines
• Remain flexible and adaptable in order to take on extra challenges on a multi-disciplinary team
• Strong organizational skills
The successful candidate will preferably have:
• Computer Science, or Engineering degree
• Experience with Java, C/C++ and/or Ant
• Experience with embedded systems
• Experience with multi-threaded programs
To apply for this position, please email your resume to jobs@kardium.com with a subject line of "Senior Systems Programmer, Medical Device Software".