Senior Software Quality Engineer - Medical Devices

| Chicago, IL, USA | Hybrid
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Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

We are looking for a Senior Software Quality Engineer (Software Design Controls) who will be involved in the software quality management system (QMS) and software development life cycle (SDLC) activities, in accordance with FDA’s Quality System Regulation (QSR), ISO 13485, CAP/CLIA, and other applicable regulatory requirements, as well as best practices in the software industry. You will report to the Manager of Software Quality and will play a key role in producing quality software products.

Responsibilities:

  • Serve as Software Quality lead for Tempus’ SDLC projects/activities that include laboratory developed tests, investigational device software, and commercialization of medical devices (SiMD and SaMD).
  • Provide FDA/ISO Design Controls mentoring to various cross-functional teams, including R&D, lab operations, software engineering, bioinformatics, and IT teams.
  • Ensure applicable quality required documentation, such as DHF deliverables, are generated and maintained throughout SDLC of software products, including SRS, SAD, SDS, V&V, traceability, risk management/FMEA and cyber-security.
  • Apply innovative, scalable, and risk-based approaches to meeting compliance for novel technologies in a fast-paced, multi-project environment.
  • Maintain knowledge of the evolving regulatory landscape for Digital Health, Artificial Intelligence and Machine Learning technologies, and incorporate best practices in Tempus’ SDLC processes and QMS.
  • Support compliance to various QMS procedures and activities including, but not limited to risk management, internal and external audits, change control, and training.
  • Support and own software QMS procedures.
  • Performs other related duties and responsibilities as assigned.

Required Education & Experience:

  • BA/B.S. or higher preferred in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines.
  • 5+ years in a software quality (design assurance/controls) role in the medical device/IVD (or FDA regulated) industry.
  • Experience and working knowledge of applicable regulations and standards: FDA QSR, ISO 13485, IEC 62304, ISO 14971
  • Expertise in SDLC best practices, and experience with state-of-the-art SDLC tools such as Atlassian (Jira) and Jama.
  • Experience with Agile/Scrum/iterative software development methodology.
  • Ability to deliver quality outputs under minimal supervision.

#LI-SH1

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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Technology we use

  • Engineering
  • Product
  • Sales & Marketing
  • People Operations
    • GolangLanguages
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • SqlLanguages
    • SwiftLanguages
    • GCPLanguages
    • ReactLibraries
    • ReduxLibraries
    • Node.jsFrameworks
    • SparkFrameworks
    • TensorFlowFrameworks
    • Microsoft SQL ServerDatabases
    • MySQLDatabases
    • PostgreSQLDatabases
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    • LookerAnalytics
    • TableauAnalytics
    • FigmaDesign
    • ConfluenceManagement
    • Google DriveManagement
    • Google DocsManagement
    • Google SlidesManagement
    • JIRAManagement
    • TrelloManagement
    • DocuSignCRM
    • SalesforceCRM
    • MarketoLead Gen
    • Google HangoutsCollaboration
    • SlackCollaboration
    • ZoomCollaboration

Location

Our Chicago office is located in downtown River North. Right on the river and close to neighborhoods like Fulton Market, Central Business District, Lincoln Park, and Streeterville, it's a lively area with convenient transportation access and is home to many bars, restaurants, and coffee shops.

An Insider's view of Tempus AI

What’s the vibe like in the office?

The casual setting here in the Chicago office makes everyone less intimidating and more approachable. It's nice to be in an environment where our day-to-day work actually makes a difference, I feel valued. Tempus is also great at welcoming everyone with different backgrounds.

Alexis

Clinical Lab Associate

How do you collaborate with other teams in the company?

I collaborate with various hiring teams on a daily basis. Through weekly meetings, strategic planning, events, and messaging, hiring teams and I have built a collaborative hiring process and have become trusted partners to bring top talent to Tempus. We rely on honest communication, shared goals, and the right tools to set us up for success!

Emma

Recruiter

How does the company support your career growth?

I am always looking for the next opportunity to grow my career, and Tempus has a wealth of opportunities in many departments. Through emerging leaders programs and ongoing conversations with my managers, Tempus has always been supportive in guiding me to find work that is fun, interesting, and maximizes my potential.

Aaron

Senior Operations Manager

What are some things you learned at the company?

One of the things that molded my growth was seeing how much thought goes into the decisions, and how much leadership seeks feedback from the people around them, to help understand the impact of decision-making. Just being a sponge in the room is inspiring. I adapted the styles of many leaders here and use that to create my own leadership style.

Anita

Laboratory Operations Manager

What are Tempus AI Perks + Benefits

Tempus AI Benefits Overview

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short-Term Disability Insurance
Flexible Spending Account
Commuter Benefits
Parental Leave
Charitable Matching Program
Employee Assistance Program (EAP)
Pet Insurance
Company Cafeteria with Breakfast, Lunch & Grab & Go Options
Stocked Kitchen with Snacks
On-Site Barista
Discounted Gym Membership
Discounted Divvy Membership
Diversity & Inclusion Initiatives
Team & Company Outings

Culture
Volunteer in local community
Open door policy
OKR operational model
Team based strategic planning
Pair programming
Open office floor plan
Employee resource groups
Employee-led culture committees
Hybrid work model
Flexible work schedule
Remote work program
Diversity
Highly diverse management team
Diversity employee resource groups
Hiring practices that promote diversity
Health Insurance + Wellness
Flexible Spending Account (FSA)
Disability insurance
Dental insurance
Vision insurance
Health insurance
Life insurance
Pet insurance
Wellness programs
Mental health benefits
Financial & Retirement
401(K)
Company equity
Charitable contribution matching
Child Care & Parental Leave
Generous parental leave
Family medical leave
Vacation + Time Off
Unlimited vacation policy
Generous PTO
All staff in Tempus’ laboratories are subject to Tempus’ separate laboratory PTO policies.
Paid volunteer time
Paid holidays
Paid sick days
Flexible time off
Bereavement leave benefits
Office Perks
Commuter benefits
Company-sponsored outings
Free snacks and drinks
Some meals provided
Company-sponsored happy hours
Onsite office parking
Recreational clubs
Relocation assistance
Meditation space
Mother's room
Onsite gym
Professional Development
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Continuing education available during work hours

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