Design Quality Manager

Our mission is to cure cancer through high performance, accessible early cancer detection. That means saving lives.

DELFI Diagnostics is a Johns Hopkins spinoff focused on the non-invasive detection of cancer at earlier stages, when it is most curable. DELFI uses artificial intelligence and whole genome sequencing to detect unique patterns of DNA fragmentation in the blood of patients with cancer. These analyses are performed through simultaneous examination of millions of DNA sequences using machine learning to identify tumor-specific abnormalities.

In our passionate pursuit to radically improve health outcomes, we serve humanity when we:

• Lead with Science, Anchor in Pragmatism: We pioneer life-changing science by ensuring quality, transparency, and rigor at all times. We explore thoughtfully, experiment smartly, and deliver impact with conviction.

• Build With & For All: We embrace diverse backgrounds to innovate and achieve together. We are not just building a product - we aim to disrupt the path of cancer for all - no matter geography or socioeconomic class

• Put We over I: We are a home for high-performing people. Through teamwork, we build collective intelligence. Each of us wins when those we serve and those who serve with us--win. We show up with empathy, humility, and integrity at every step of the journey.

DELFI has 1-2 designated in-office working days each week for employees who live within within 50 miles of Palo Alto, CA.

About the Role In this role, you will lead and develop DELFI’s Design Quality, Risk Management, Process Validation, and Equipment Qualification programs from a Quality perspective. You will provide Quality oversight and guidance to ensure compliance and that effective processes are maintained, per applicable regulatory requirements and company procedures. In addition, you will act as a key coordinator of our Regulatory submission documents (e.g., DHFs, Plans, etc.), assessing the requisite documentation from a quality perspective.

What You’ll Do

• Provide Design Quality leadership and guidance for product development (includes LDT and IVD), design control (e.g., design and development planning, training, design input, design output, design review, design verification, design validation, design transfer, product design changes, and design history file (DHF)), risk management, change management, process validation/controls, and equipment qualification.

• Provide Design Quality leadership and guidance for IVD product development in compliance with FDA 21 CFR 820 QMSR/ISO 13485

• Support the development teams in aligning our product development execution strategy with Design Control and Risk Management procedures

• Provide guidance, training, review, approve user needs, design input, design control plans, requirements, specifications, protocols/reports, design outputs, design transfer, and risk management documents.

• Lead in partnership with the cross-functional team by facilitating and supporting risk activities, including FMEAs- dFMEA, pFMEA, and use-related risk analysis- from hazard identification through risk control verification and residual risk evaluation. Own the Risk Management Plan and Report, support cross-functional working sessions to current and complete state, and ensure risk file linkage to design outputs, V&V evidence, and labeling.

• Provide support for the preparation of PMA modules/documents and supporting documents to be submitted- including design control and risk management content, and assist in responding to FDA information requests in those areas.

• Drive cross-functional alignment on design documentation. Set consistent standards for the quality of document types, content, lexicon, and level of detail. Ensure DHF design control evidence is submission-ready as it's generated; track/monitor oversight of documentation progress against timelines accordingly

• Lead remediation of existing design and risk documentation. Assess previously created design control and risk management documents and align according to established procedures, design documentation strategy, and documentation standards.

• Support the development teams in aligning our product development execution strategy with our Design Control and Risk Management procedures. Review, approve, and audit Design History File (DHF) elements (e.g., plans, requirements, specifications, test protocols/reports, design traceability, and risk management documents).

• Maintain the section-level inventory of every document required in the DHF, mapped to ISO 13485 with named author, reviewer, approver, and due date for each.

• Review and approve design control, risk management, product change management, production, verification/validation, equipment qualification documents per applicable regulatory requirements and company procedures.

• Provide support for the preparation of pre-submissions, sprints, and PMA modules/documentation.

• Train and mentor cross-functional peers and junior team members on best practices for maintaining compliance with the applicable Quality Management System (QMS) requirements and regulations.

• Author, revise, review, and approve standard operating procedures and other controlled documents.

What You'll Bring to DELFI

Required

• Bachelor’s degree in Science, Engineering, or a related field with 8+ years of relevant experience; or Master’s degree with 6+ years; or equivalent.

• Experience in Design Quality or a directly related function within the IVD or medical device industry.

• Advanced working knowledge and experience in the application of FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements.

• Demonstrated strategic and tactical leadership building a high-performance results driven team.

• Strong interpersonal and communication skills, including written and verbal communication, and presentation experience.

Required

• Previous experience in a regulated laboratory and product development environment for in-vitro diagnostics (IVD).

• Prior experience with coordinatoring, reviewing and supporting regulatory submissions.

• Ability to influence, build, and foster relationships horizontally and vertically across the organization.

• Ability to address and resolve a variety of complex issues diplomatically.

• Molecular diagnostics background.