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.

Responsibilities:

Support 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 the team

Assist in the determination of appropriate deliverables and generating project timelines.

Supports the sustainability and life cycle management of existing products

Ensures compliance with quality system and regulatory requirements related to product and process

Provide Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development

Evaluate adequacy of specifications for new or modified process designs.

Support product and customer requirement definition and development

Participate in Design Verification, Validation, and Process Validation Planning, Protocol Review, Report Review.

Recommends design or test methods and statistical process control for achieving required levels of product reliability.

Reviews and analyze performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.

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 collaboration with the Risk Manager as they relate to product development and post market surveillance requirements

Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities)

Support development master validation plans and reports.

Provide technical support (subject matter expert) during audits (internal and third-party)

Prepare 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

Develop/update departmental procedures and other controlled documents.

Participate in Material Review Board (MRB) and Change Review Board meetings, as required.

Train and mentor new employees. Provide guidance and direction to the team.

Plans, executes, and works with minimal supervision and independent judgment

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.

Extensive cross-functional team experience, including technical and non-technical work.

Strong interpersonal and communication skills.

Strong leadership skills and ability to work in a team environment

Highly motivated hands-on engineer with a proven record of meeting timelines and goals

Education and Experience:

B. S. degree in Degree in a chemistry, biology, or engineering discipline is a plus with 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 $65,000 — $115,000/year