Software Quality Engineer - Medical Device
Machine learning is eating the world. At PathAI, we're applying it in amazing ways to pathology, healthcare, and detecting cancer and other diseases. We're applying our work to drug development, the clinical space, and as a global health initiative. Since it's early days for us, there's a lot of work to do and a lot of great product to build, and ensuring regulatory compliance is critical to the success of everything we aspire to do.
We're looking for a software quality professional with at least 5 years’ experience in the Software Medical Device industry. As we are expanding our business and products, we are building the quality assurance team. In this role, you have the opportunity to contribute to growing the team and to developing your own challenging, rewarding career path.
If you're the right candidate, you'll be exercising all the skills you have in this role, and building new ones along the way, including:
• Conducting software validations including plans, protocols and reports
• Supporting the QMS
• Supporting product development teams in the design of Software as a Medical Device
• Serving as the consultant for engineering and manufacturing teams throughout the design control process
• Supporting the compliance process in all phases of design and development, manufacture, and product release
*Minimum bachelor’s degree in an appropriate scientific or other related field
• At least 5 years’ experience in the software quality environment within the Medical Device industry
• Hands-on ability to work autonomously to problem-solve, demonstrating excellent analytical skills
• Experience with implementation of ISO 62304
• Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971
• An insatiable intellectual curiosity and the ability to learn quickly in a complex space and help to shape the regulatory team
• Excellent verbal and oral communication skills
For the right candidate, we'll offer a competitive salary plus equity. We have a strong benefits package, including heavily-subsidized health, dental, and vision insurance plans to keep you in peak shape. It's rounded out by:
• Flexible work hours
• Three weeks of paid leave per year, plus holidays and extended leave
• Convertible sit-stand desks
• Your choice of computer equipment
• Free lunch on Fridays
• Snacks and drinks in the office – which currently include a mountain of Milano cookies and cold brew coffee and green tea on tap.
Most importantly, you'll be doing important work with a team of people you'll enjoy spending the day with.
PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way.