Principal Quality Engineer
Westford, MA /
At MedAcuity, we work at the intersection of healthcare, technology and innovation in partnership with MedTech companies and innovators to develop custom software for their next-generation software-driven medical devices and solutions. We are looking for a Principal Software Quality Engineer who wants to apply their exceptional technical skillset and problem-solving acumen to develop innovative, secure, safe and reliable software to support the product development needs of our MedTech clients.
As a thought leader with a depth and breadth across multiple disciplines and technologies, this role will lead and develop testing of software throughout the product development lifecycle. As a subject matter expert, you will own projects and lead teams of engineering professionals, mentoring on best practices, and driving process improvements.
- 13+ years’ experience performing the same or similar type of work as required by the position in compliance with experience in class 3 medical device
- Class 3 medical device verification and validation experience or equivalent
- Bachelor’s Degree in Computer Science or Computer Engineering is preferred
- Strong working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO14971
- Strong technical writing skills, including development of test methods, protocols, reports
- Proven ability to communicate complex technical material to a variety of audiences at multiple technical levels
- Demonstrated commitment to high quality
- Exceptional understanding of the software development life cycle
- Demonstrated ability to document complicated designs and architectures in a clear and concise manner
- Excellent communication skills and the ability to work with high level stakeholders and management teams to help guide them in their decision-making process
- Experience in high performing Agile/Scrum environments
- Professional services or consulting environment expertise and know-how, ideal
- Experience working in a regulated environment such as medical device, DOD, Aerospace, ideal
Applicants for employment at Medacuity, LLC are considered without regard to race, color, religion, sex, sexual orientation, gender-related identity/appearance, pregnancy, age, genetic information, national origin, status as a Vietnam Era or disabled veteran or membership in the uniformed services, physical or mental disability, or any other legally-protected classification.
MedAcuity is an equal opportunity employer.