Program Manager - IVD

A well-funded, fast-growing digital diagnostics company is seeking a Program Manager – Digital IVD to lead end-to-end product development across a portfolio of connected in-vitro diagnostic devices.

The role spans products integrating lateral flow chemistry, compact imaging systems, and AI/ML-driven interpretation
, and requires strong ownership of design controls, regulatory execution, and cross-functional delivery across biotech, software, and hardware teams.

This is a highly visible role with direct influence on product strategy, execution, and regulatory readiness.

• Lead cross-functional engineering teams to translate lab-stage prototypes into scalable, real-world home diagnostic products.
• Own Design Control execution across multiple Digital IVD programs, ensuring compliance with ISO 13485 and 21 CFR 820.30
  .
• Translate clinical and market needs into clear MRDs and PRDs
  , maintaining full traceability through verification and validation.
• Plan and oversee execution across distributed teams covering biotech, software/AI, and mechanical/packaging development
  .
• Run sprint-based development within a regulated design control framework - maintaining velocity without compromising compliance.
• Drive risk management activities including DFMEAs
  , and ensure high-quality Design History Files (DHFs).
• Track cost, schedule, and risk across programs, ensuring readiness for clinical, regulatory, and manufacturing milestones.
• Guide development of both hardware-integrated and smartphone-based Digital IVD platforms
  .

• Partner closely with assay and reagent teams to ensure analytical performance consistency from R&D through manufacturing scale-up.
• Work with AI and data science teams to ensure model development aligns with Good Machine Learning Practices (GMLP) and SaMD regulatory expectations
  .
• Oversee software development aligned with SDLC and SaMD documentation standards
  .
• Drive design for manufacturability and usability across mechanical and packaging development.
• Support preparation for FDA and CE-IVDR submissions
  , and post-market activities where required.

• Successful delivery of Digital IVD programs meeting analytical, usability, and regulatory performance goals.
• Predictable execution across assay, hardware, software, AI, and manufacturing streams.
• Audit-ready Design History Files across programs.
• Establishment of a repeatable program execution framework to support future diagnostic launches.

• 5+ years’ experience managing regulated product development (IVD, medical devices, or SaMD).
• Strong working knowledge of design controls, risk management, and regulatory submissions
  .
• Technical fluency across diagnostics, lateral flow systems, imaging-based assays, or connected medical devices.
• Proven experience leading multi-site, cross-disciplinary R&D teams
  .
• Comfortable operating in a fast-paced, startup environment with high ownership and limited hierarchy.