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.

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