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 and Manufacturing teams to ensure that Kardium's cutting-edge medical devices meet high-quality standards.
What you'll be doing
As the Quality Control Engineer, your responsibilities will include:
- Creating and maintaining quality control specifications for incoming components and in-process inspections in collaboration with Engineering and Risk Management teams.
- Performing trend analysis for incoming and in-process inspection results, and implementing continuous improvement programs to enhance the quality of Kardium products.
- Writing technical documentation related to quality control, such as quality control work instructions and quality control test protocols.
- Assessing the supplier's first article inspection documentation.
- Developing and qualifying new testing methods using measurement system analysis methodologies, such as gauge repeatability and reproducibility (gauge R&R).
- Performing inspections on incoming components and in-process products as required.
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 mechanical, biomedical, applied physics, or similar; at least 3 years of quality experience in a multi-disciplinary environment in a regulated industry.
- Experience creating inspection plans and first-article inspection reports (FAIR) for new products based on mechanical drawings, as well as selecting the appropriate measurement tools for each measuring characteristic.
- Knowledge in Statistical Process Control, FMEA, MSA, and AQPQ is desirable.
- Experience using Lean Manufacturing tools to reduce waste in manufacturing and office environment is desirable.
- Well-developed interpersonal skills with the ability to interface effectively across multiple functions and at various levels of the organization.
- Demonstrated leadership skills and ability to drive results on time.
- The willingness and ability 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!