Senior IVD Product Development Scientist
AOA
Product
Denver, CO, USA
Posted on Mar 20, 2026
Introduction
AOA Dx exists to transform women’s health. We are leading the next generation of cancer diagnostics, applying lipidomics, proteomics, and machine learning to enable earlier diagnosis of ovarian cancer for women with signs and symptoms - an area where no diagnostic tool exists today.
The Opportunity
AOA Dx is seeking an experienced Senior Product Development Scientist who will play a key role in advancing the company’s diagnostic assays through late-stage, cancer-focused IVD development. This individual will lead and execute analytical validation, design verification and validation (V&V), design transfer, and regulatory submission activities to transition R&D assays into robust, manufacturable, and clinically validated products, advancing programs from late-stage development through regulatory approval.
This role requires a strong technical foundation in IVD product development, experience working within regulated environments, and the ability to collaborate cross-functionally to drive programs toward commercialization.
Key Responsibilities
Late-Stage Assay Development & Validation
- Lead the planning, design, and execution of analytical validation and design V&V studies for IVD assays
- Develop and implement validation strategies aligned with FDA, CLIA, CAP, and ISO 13485 requirements
- Ensure comprehensive documentation, traceability, and adherence to design control processes
Regulatory Submission
- Partner with R&D leadership and Regulatory Affairs to prepare data packages for FDA submissions (510(k), PMA, De Novo) and CLIA LDT validations
- Translate scientific data into clear, regulatory-ready documentation, summaries, and justifications
- Support regulatory interactions, including audits, technical reviews, and information requests
Cross-Functional Collaboration
- Work closely with R&D, Clinical, Regulatory, Quality, Operations, and Program Management to align on timelines, risks, and deliverables
- Collaborate with Manufacturing and Operations to enable successful design transfer, scale-up, and reproducibility
- Contribute to cross-functional planning to support late-stage development and commercial readiness
Technical Leadership
- Provide scientific guidance and technical oversight to scientists and research associates
- Support experimental design, data interpretation, and troubleshooting of complex assay challenges
- Promote a culture of quality, accountability, and continuous improvement
Program & Project Ownership
- Develop and manage project plans, including timelines, resource allocation, and risk mitigation strategies
- Communicate program status, risks, and key milestones clearly to internal stakeholders and leadership
Qualifications
- PhD or master’s degree in molecular biology, Biochemistry, Analytical Chemistry, Biomedical Engineering, or related field
- 3+ years of experience in IVD development, including V&V, analytical validation, and late-stage product development
- Proven experience supporting FDA regulatory submissions (510(k), PMA, De Novo) or CLIA LDT development
- Strong working knowledge of design controls, risk management (ISO 14971), quality systems (ISO 13485), and documentation standards
- Demonstrated ability to manage complex cross-functional projects
- Experience in design transfer, manufacturing scale-up, or sustaining engineering for IVDs
- Familiarity with clinical trial design or clinical laboratory operations
- Experience with multi-omics or biomarker-based diagnostics is a plus
- Preferred experience developing cancer-based IVD assays
- Preferred experience with mass spectrometry, immunoassay, proteomics, or other complex diagnostic platforms
- Preferred experience in a fast-paced biotech start-up
Why Join AOA Dx
Impact & Ownership
- Contribute to a first-in-class diagnostic platform focused on early cancer detection in women
- Play a visible role in advancing a technology designed to change clinical outcomes
Equity & Performance Alignment
- All full-time employees participate in a structured stock option program
- Equity aligned with company milestones and performance
- Bonus pool and recognition programs designed to reward impact and culture embodiment
- Employee referral program
Compensation & Benefits
- Competitive base salary
- 401(k) with employer match
- Comprehensive medical, dental, and vision coverage
- Employer-sponsored life and disability insurance
- Unlimited PTO
AOA Dx is an equal opportunity employer (EOE) and welcomes candidates from all backgrounds. We foster an environment where all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation or expression, age, disability or veteran status or any other characteristics protected by law.
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