Senior Software Quality Engineer - Medical Device

| Greater Boston Area
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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 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

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.


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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • VueJSLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

We're right in Fenway! One of our perks is Red Sox tickets.

An Insider's view of PathAI

What kinds of technical challenges do you and your team face?

Automating and auto-scaling a generalized machine learning workflow that takes pathologists from a slide medical image to a clinical prediction

Mariel

Senior Platform Engineer

What are PathAI Perks + Benefits

PathAI Benefits Overview

PathAI offers a standard benefits package (health insurance, 401k, stock options) in addition to some fun perks, listed below!

Health Insurance & Wellness Benefits
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
PathAI covers 85% of the premium for individuals and 75% for families
Retirement & Stock Options Benefits
401(K)
Company Equity
We don't offer a 401(k) match yet because we're still in Series A funding round. We'll be rolling it out soon, though!
Child Care & Parental Leave Benefits
Generous Parental Leave
All employees receive a free membership to care.com to help with childcare needs
Flexible Work Schedule
PathAI employees make their own schedule (with their manager's approval)
Remote Work Program
We are very remote-friendly
Family Medical Leave
Vacation & Time Off Benefits
Generous PTO
We do three weeks PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Beer on Tap
Not on tap, but in the fridge. We have green tea, iced coffee, and kombucha on tap, though!
Casual Dress
Commuter Benefits
Company Outings
We have season tickets for the Red Sox!!
Game Room
Our game room has a PS4!
Stocked Kitchen
Fruit snacks, milano cookies, seaweed snacks, fresh fruit, pop tarts, cereal, kind bars, etc. You can also request any specific snacks you would like on hand by asking our front desk associate
Some Meals Provided
We do a catered lunch for the entire company every Friday
Happy Hours
Whiskey Wednesday!!!
Parking
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
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