Principal/Staff Design Quality Engineer

| Chicago, IL, USA | Hybrid
Sorry, this job was removed at 2:17 p.m. (CST) on Friday, March 8, 2024
Find out who's hiring remotely in Chicago.
See all Remote Cybersecurity + IT jobs in Chicago
Easy Apply
By clicking Apply Now you agree to share your profile information with the hiring company.

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.

The Quality Assurance team at Tempus is in search of a Staff Design Quality Engineer to support the development of our IVD products & laboratory developed tests. This key leadership role will serve as a cross-functional collaborator to ensure compliance, build process improvements and solutions for our product offerings. 

Key Responsibilities:

  • Responsible for supporting the development of new or improved In Vitro Diagnostics products and Laboratory Developed Tests as core team Design Quality Engineering lead; providing collaborative, solution-oriented technical guidance and support to Tempus. 
  • Assist in the determination of appropriate deliverables and generating project timelines as well as sustainability & life-cycle management of existing products.
  • Ensure compliance with quality systems and regulatory requirements related to product, process, specification & process design.
  • Provide Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development
  • Participate in Design Verification, Validation, and Process Validation Planning, Protocol Review, Report Review.
  • Performs design change control activities including impact assessments, reviews, and approvals
  • Takes lead role in CAPA, non-conformances, and planned deviations activities such as investigation, implementation, or verification of effectiveness as required
  • Supports risk management activities in relation to product development and post market surveillance requirements
  • Provide technical support (subject matter expert) during audits (internal and third-party)
  • Prepare and develop documentation to support design history files and regulatory submissions, ensuring documents are complete and accurate.
  • Maintain DHF and Propose, plan and execute improvement projects, as required for product sustainability
  • Participate in Material Review Board (MRB) and Change Review Board meetings, as required.

Qualifications:

  • Must have experience working with all classes of Medical devices preferably IVDs in a QE role;  previous CDx experience a plus
  • Ability to demonstrate proficiency in design of experiments, IVDD/IVDR requirements, Risk management file generation and remediation, problem analysis and resolution.
  • Demonstrates leadership skills to handle sustaining product support activities involving Complaint investigations and Change controls.
  • Product life cycle management experience, medical device experience, design development and transfer experience
  • Extensive leadership skills & cross-functional team experience, including technical and non-technical work.
  • Strong interpersonal and communication skills.

Education and Experience:

  • B.S. degree in Degree in chemistry, biology, or engineering related discipline
  • 7+ years of experience working in a regulated environment in the in-vitro diagnostic, medical device, biotech or pharmaceutical industry. 
  • Advance knowledge of applicable regulations including:  21 CFR Part 820, ISO 13485, ISO 14971
  • Experience with process validation, analytical methods validation, and equipment qualifications.
  • Demonstrated success in delivering results on several technical challenges.
  • Working knowledge of medical device domestic and international standards.

#LI-SH1#LI-Hybrid#LI-Onsite

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.

Read Full Job Description
Easy Apply
By clicking Apply Now you agree to share your profile information with the hiring company.

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
    • SQLiteDatabases
    • 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 Benefits
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 Benefits
Generous parental leave
Family medical leave
Vacation & Time Off Benefits
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 Benefits
Job training & conferences
Lunch and learns
Promote from within
Mentorship program
Continuing education available during work hours

More Jobs at Tempus AI

Easy Apply
By clicking Apply Now you agree to share your profile information with the hiring company.
Learn more about Tempus AIFind similar jobs like this