Principal 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.

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.

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