The Senior Software Quality Engineer is responsible for ensuring product quality during the software development life cycle, involving design, verification, and validation processes.
Candidates should have at least eight years of experience in quality engineering within regulated industries, with knowledge of ISO standards and the ability to conduct risk management and internal audits.
Client Details
My client is dedicated to improving patient outcomes through innovative diagnostic technologies for treating atrial fibrillation.
Founded in 2016, the company focuses on delivering patient-specific treatment solutions, emphasizing that one-size-fits-all approaches do not work in electrophysiology?
My clients flagship product, the VidereX catheter, showcases its commitment to advanced medical technology and precision healthcare?.
With a dynamic and diverse team, my client has raised significant funding to support its growth and development, reflecting confidence in its mission and leadership.
The company operates within a collaborative environment, attracting talent committed to making a difference in the healthcare industry.
Description
Senior Software (Medical Device) Quality Engineer :
- Quality Systems representation
- Risk Management
- Cross Collaboration
- Material & Process Inspection
- Internal Audits
- Documentation & Reporting
- Culturally - self sufficient, independent contributor, highly technical work
- Attention to detail & documentation - need someone to adapt to small organization
Profile
Senior Software (Medical Device) Quality Engineer :
- B.S. degree
- 8+ years of experience in Medical Device (ideally class 2 or more complex)
- New Product Development experience
- Experience working with systems using input signals to display visualization
- Start up experience
- Knowledge of 21 CFR 820, ISO 13485 : 2016, and IEC 62304 : 2006
- Experience with C++ & Python
Job Offer
Offered :
- High compensation & bonus
- PTO & Vacation
- Stock Options
- Standard benefits
- Experience to grow rapidly in a start up environment
- Working with cutting edge, brand new to the market products
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law.
MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
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