Medical Device Systems Engineer
5 hours ago
Endotronix is a medical device company dedicated to transforming the treatment of heart failure. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure.
Job SummaryWe are seeking a highly skilled Systems Engineer to join our Research & Development team. As a key member of our team, you will be responsible for new product design and development, risk management, and product performance improvements for the hardware components of the Cordella platform.
Key Responsibilities- Verification and validation testing, including test method development, protocol writing, test execution, data analysis, and report writing
- Design change impact assessments
- Risk management activities, including Hazard Analysis, Design FMEAs, and Use FMEAs
- Standards compliance
- User research and usability assessments/validation
- Build and maintain the design history file
- 3-5 years medical device engineering experience
- Prior experience performing testing to support V&V and risk management activities for medical device development
- Prior experience working within Design Controls and DHF ownership
- Prior experience processing, parsing, and analyzing data, including script development for automation and statistical analysis methods using Excel and Minitab
- Demonstrated ability to work independently with minimal supervision
- Excellent oral and written communication skills, particularly in technical writing, documentation, and presentations
- Demonstrated organizational, interpersonal, and critical thinking skills
- Experience with medical devices and FDA quality practices and standards, including ISO 13485
We provide a competitive compensation package, comprehensive benefits, and an environment that will help you to thrive and succeed in your career. Endotronix is an equal opportunity employer, and we are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, gender, marital status, citizenship status, age, veteran status, or disability.
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