SpectraWAVE

SpectraWAVE, located in Bedford, MA, is a privately held medical device company founded in 2017 to improve coronary artery disease (CAD) outcomes with photonics. CAD, the buildup of plaque in the wall of the arteries that supply blood to the heart, affects 18.2 million adults age 20 and older. In CAD patients that undergo percutaneous stent placement, it is estimated that one in five patients experience adverse events, with half of those adverse events caused by high risk plaques that were previously left untreated. The SpectraWAVE medical imaging platform is a state-of-the-art integration of proven imaging technologies - designed to help interventional cardiologists understand their patients and optimize interventions.

Jun 03, 2021
Job Summary We are seeking a qualified Senior Quality Engineer to provide quality assurance oversight and support for our medical device development.  This individual will facilitate the application of design controls, risk management and usability for complex electromechanical medical devices that include software and sterile, single-use disposables. The right candidate will have a successful track record of hands-on experience with the development and implementation of processes to design, assess, and monitor new and sustaining product development. In addition, this individual will help develop, establish and maintain quality methodologies, systems, and practices to facilitate product development, operations, and related functions to meet corporate requirements. Key responsibilities Provide design assurance support and leadership in the design and development of medical device products. Key contributor, advisor and reviewer of verification and validation methods and...
SpectraWAVE Bedford, MA, USA Full time
Jun 03, 2021
Job Summary We are seeking a Senior/Principal Software Quality Engineer to join our talented team and provide software quality assurance leadership and support for our medical device development.  This individual will facilitate the application of design controls, risk management and usability, with a focus on software, for complex electromechanical medical devices that include sterile, single-use disposables. The right candidate will have a successful track record of hands-on experience and leadership with the development and implementation of processes to design, assess, and monitor new and sustaining product development. In addition, this individual will help develop, establish, and maintain quality methodologies, systems, and practices to facilitate software product development, and related functions to meet corporate requirements. This position reports to the VP of QA/RA and is a critical member of the product development team. Key responsibilities Develop,...
SpectraWAVE Bedford, MA, USA Full time