Principal/Staff Design Quality Engineer
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.
- 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.
- 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.
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.