Medical Device Program Manager at PathAI

| Greater Boston Area
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At PathAI, we're applying Computer Vision, Machine Learning and AI 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 is a lot of work to do and a lot of great products to build, and a product-driven approach is critical to the success of everything we aspire to do.

Reporting to the Chief Scientific Officer, the Medical Device Program Manager will be accountable for delivering the end to end execution strategy (concept to global launch and end of life) of all medical device development programs at PathAI. This is a highly matrixed and cross functional role responsible for leading and motivating a complex cross functional team from several functions including product, engineering, scientific programs, regulatory, clinical affairs, quality and commercial. 

The Medical Device Program Manager will define the medical device program plan and drive successful project / program execution including identifying and communicating risk and mitigation options at the programmatic level to senior management. The successful candidate will be a skilled communicator and have a track record of fostering an environment of collaboration, innovation, flexibility and performance as it relates to delivering complex software based medical devices on time and on budget. 

Responsibilities:  

  • In collaboration with core team members, be responsible for the creation of the program and project work breakdown structures that integrates key deliverables at various stages of medical device development.
  • Be the single accountable owner of the overarching medical device development process from concept to end of life
  • Set budget, staffing, tools (resources) and timeline projections for the entire scope of the medical device program and ensure the functional teams fulfill their responsibilities in accordance with the project plan and in compliance with PathAI’s standards, QMS and required regulations
  • Understand product complexity as it relates to all cross functional requirements and work to resolve conflicting requirements across teams. Strive for team alignment and buy-in for complex trade-off decisions.
  • Develop an operating model that allows for communication of program progress and programmatic risks to senior management and work with team members to evaluate and present alternative solutions to effectively resolve problems and/or mitigate barriers to the timely delivery of the program. 
  • Serve as medical device development subject matter expert and bring best practices to the team while maintaining a strong degree of flexibility and approaches that are right sized for a fast growing technology start-up.
  • Have a deep appreciation for patient safety and quality/compliance risks and be able to propose an acceptable level of risk consistent with comprehensive business needs.
  • Build and foster a cohesive team environment through transparent and candid communication

Requirements

  • BS degree in Mechanical Engineering, Materials Science & Engineering, Biomedical Engineering or equivalent is required. An advanced degree in an engineering discipline or MBA is preferred.
  • At least 10 years relevant experience in product development and design with at least 5 years product development and design experience in complex medical devices/products.
  • Outstanding interpersonal, communication, presentation and influencing skills
  • Experience in new product development planning multiple work-streams, identifying risk and implementing action plans to optimize time lines and reduce execution risk
  • Have full knowledge of related disciplines needed to execute the program, including software development, quality engineering, regulatory guidances and product development best practices

Preferred Skills:

  • PMP certification or equivalent is preferred
  • Experience in agile software development in context of medical device development
  • Experience in human factors testing per FDA regulations
  • Has successfully launched multiple new medical device products from concept through launch.
  • Understanding of the in vitro diagnostic device development
  • Understanding of complex medical devices including imaging technologies

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

How would you describe the company’s work-life balance?

We’re really flexible - there are no on-call shifts, and you can work from home when you need to. A lot of my colleagues have young children and they can be there for their family. We all work hard, but the work is task-oriented and day-to-day workload is actually realistic.

Sarah

Senior Product Manager

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 makes someone successful on your team?

Someone who is willing to roll up their sleeves and do what it takes to get the job done will do well here! Since we're a small startup, we all wear multiple hats, so a willingness to adapt, be flexible, and learn from one another is really important.

Diana

Product Manager

How do you empower your team to be more creative?

We hire smart people to solve hard problems early on, and just let them do their thing.

Jackson

VP-Product

What's the biggest problem your team is solving?

We’re using computer vision to increase the speed and accuracy of cancer diagnosis, making personalized medicine accessible to more patients and ultimately improving treatment outcomes.

Sam

Front-end 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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