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.
In this role, you will work closely with the Engineering, Manufacturing and Clinical teams to ensure that Kardium's cutting-edge medical devices meet high-quality standards.
What you'll be doing
We seek a strong technical contributor who can identify key opportunities for product quality improvement, launch quality engineering initiatives, lead projects to implement these initiatives, and serve as an expert consultant to help solve technically challenged quality problems.
- Perform preliminary investigations of product quality issues reported from the field to assist in more accurate triage.
- Coordinate hands-on investigation of devices returning from the field with subject matter experts, analyze results, determine root cause, and initiate appropriate actions.
- Identify and report key field issues to inform manufacturing and design engineering teams on potential improvements to process controls or product design.
- Complete all internal documentation for investigations on reported field issues, including participation in escalation tasks such as corrective/preventive action(s).
- Other related duties assigned by Leadership (may assist in key complaint metric reviews)
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:
- A Bachelor of science or engineering degree in biomedical, mechanical, system or applied physics.
- Quality engineering experience in a multi-disciplinary environment in a regulated industry (i.e. familiarity with ISO 13485 and US FDA Quality System Regulation) is strongly desirable.
- Ability to learn quickly and understand complex products and processes.
- Proven experience with taking the lead with troubleshooting techniques, problem-solving, and root cause analysis.
- A sound knowledge of statistics is strongly desirable.
- Proven written and verbal communication and technical documentation skills.
- Well-developed interpersonal skills with the ability to interface effectively across multiple functions and at various levels of the organization.
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!