355 Biomedical Engineer
By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have recently commercialized a ground-breaking medical device for minimally invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other conditions affecting patient quality of life.
In this role, you will gain hands-on experience specifying, performing, and overseeing various verification and validation focused engineering activities on complex and leading-edge medical devices. Your work will necessitate interactions with all parts of the company including design engineering, clinical research, field operations, regulatory affairs, testing, and manufacturing. You will have an excellent opportunity to gain a comprehensive understanding of the development lifecycle of Class III medical devices, while also performing detailed technical work.
What you’ll be doing…
You will be engaged in a diverse set of activities including the following:
- Help to coordinate sample acquisition, sample preparation, and testing for biocompatibility validation, sterilization validation, and cleaning validation and monitoring activities
- Perform design of experiments to characterize manufacturing processes and assess process capability
- Validate verification and validation tests using statistical methods and analyzing data using Excel and Minitab
- Execute verification and validation testing activities to evaluate product performance
- Author protocols and reports to support regulatory submissions for new and existing products
What you bring to the team…
Our Kardium team is smart, creative, and passionate about developing innovative 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’s degree or higher in engineering (mechanical, chemical, or biomedical engineering is preferred)
- At least 3 years of engineering experience in the medical device industry
- Practical knowledge of medical device standards (e.g. ISO 10993, ISO 11135, ISO 13485), experimental design, and statistical analysis
- Excellent collaboration and interpersonal skills
- Strong written and technical documentation skills
- Ability to manage multiple tasks with a high degree of accuracy and timeliness
Why work at Kardium?
Working at Kardium provides:
- The opportunity to advance medical devices that will improve people’s lives
- Involvement in the development of a high-complexity medical device
- A great working environment with opportunities to develop your skills and knowledge
- An engaged leadership team who believes in mentoring and career growth
- Supportive colleagues and fun social events to foster teamwork
- Competitive compensation, including equity participation
- Our employees think we are great too – check out Glassdoor to learn more!
How to apply…
To apply for this position, please send your cover letter and résumé to firstname.lastname@example.org quoting 355 Biomedical Engineer in the subject line.
Please note only candidates who are currently legally authorized to work in Canada will be considered for this position.
Thank you in advance for your interest in working at Kardium!
To apply for this job email your details to email@example.com.