268 Mechanical Test 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 verification and validation activities on complex and leading-edge medical devices. Your work in verification and validation will necessitate interactions with all parts of the company including design engineering, clinical research, field operations, regulatory affairs, and manufacturing. You will have an excellent opportunity to gain a broad and comprehensive understanding of medical device R&D, while performing detailed technical work.
What you’ll do…
You will engage in a diverse set of activities including some or all of the following:
- Plan and execute hands-on testing activities to evaluate product performance
- Develop and executing formal tests to optimize manufacturing processes and measure process capability
- Author protocols and reports to support regulatory submissions for new and existing products
- Design and fabricate test jigs and fixtures using Solidworks, CAMWorks, CNC mills and lathes
- Perform design of experiments to characterize manufacturing processes and assess process capability
- Validate tests using statistical methods and analyzing data using Excel and Minitab
- Interpret and implement medical device standards and regulations
- Collaborate with stakeholders to assess process or design changes on verification and validation
- Participate in root cause investigations, corrective and preventive actions
- Drive continuous improvement of company procedures as they pertain to verification and validation
- Author protocols and reports to support regulatory submissions for new 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, mechatronics, or engineering physics is preferred)
- At least 3 years of testing or design experience in the medical device industry, or 5 years of hands-on experience with mechanical/hardware product testing desired
- Practical knowledge of mechanical systems, 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 using “268 Mechanical Test Engineer” as the subject line.
Thank you in advance for your interest in working at Kardium!
To apply for this job email your details to email@example.com