: Senior 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.


Responsibilities

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

Requirements

*Minimum bachelors 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

Benefits

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.

PathAI does not accept unsolicited submissions from third-parties.

Full-time

Employee Testimonials

PathAI employee testimonial
Archit Khosla
Full-Stack Engineer

The work is challenging and motivating — I always know there's something interesting ahead of me as I start the day.

PathAI employee testimonial
Arti Chhajta
Sr. Product Manager

Working with amazing people to build products that have the potential to enhance the lives of so many patients is truly a rewarding experience.

PathAI employee testimonial
Megan Pitts
Administrative Manager

I've never been as excited to come to work every morning as I am here and I take great pride knowing I get to be a part of something so impactful.