By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the minimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, heart failure, and other heart-related complications.
Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.
As an integral part of the Quality Engineering team, you will have the opportunity to work across the biomedical research, electrical, usability, and risk management domains. Your daily activities will center around supporting and influencing product design and process 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 design analysis and ensuring all regulatory standards are met.
Your opportunity
As the Electrical System Risk Engineer your responsibilities include:
- Work closely with the Electrical design team to understand product design in-depth, and analyze and document safety risks.
- Provide guidance in design and development of safety risk mitigations by contributing to design input requirements and part reviews.
- Perform impact analysis of system design changes and new features on the risk profile of the device in accordance with ISO 60601.
- Contribute to development and implementation of test and verification protocols.
What you bring to the team
Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people's lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable.
You are suited to our approach and possess these attributes:
- Bachelor of Science or Engineering degree, with emphasis on electrical systems
- A minimum of 3 years' experience in a regulated industry, preferably in 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.)
- Excellent written and verbal communication and technical documentation skills
- Strong analytical and interpersonal skills
- Excellent engineering aptitude and ability to come up to speed quickly on complex subject matter across multiple disciplines
- Flexible and adaptable to meet the needs of varying production schedules, and to take on additional responsibilities as appropriate
Why work at Kardium
A meaningful career working with a truly innovative technology and an ambitious team, combined with:
- Knowing every day that you are making a difference in people's lives by helping treat a condition that debilitates millions worldwide
- A great working environment with opportunities to develop your skills and knowledge
- Opportunity to extend your knowledge by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engineers, biologists, and specialists in human factors, and clinical and regulatory affairs
- An engaged leadership team who believes in mentoring and growing employees' careers
- Supportive and fun colleagues with plenty of social events to encourage people connections
- And our employees think we are great too – check out Glassdoor to learn more!
Thanks in advance for your interest in Kardium!
