Research and Development Program Manager

Program Manager – Medical Devices / DiagnosticsThe Program Manager will lead cross-functional execution across an existing diagnostic platform and related product initiatives. The first major charter is to drive the engineering work required for CE/IVDR readiness of the existing product. Over time, the role will take on new product development programs — such as new fertility tests, sperm testing, saliva-based platforms, or other priorities based on the company’s product cadence.The role demands a strong understanding of design control, regulated product development, and agile execution across assay, hardware, software, data, manufacturing, and quality teams.Core ResponsibilitiesOrchestrate engineering teams to move product lifecycle programs and future diagnostic products from defined goals to completed, validated outcomes.Own program execution under Design Control for product lifecycle work and future regulated product programs, ensuring engineering activities are completed in line with ISO 13485 and applicable regulatory requirements.Translate market, regulatory, and product needs into clear requirements and execution plans, maintaining traceability through verification and validation.Plan and oversee cross-functional execution across Assay, Reader/Hardware, Software/App, Data Science/AI, Mechanical/Packaging, Manufacturing, and Quality/Regulatory teams.Run sprint-based execution under a design control framework — maintaining velocity without sacrificing compliance, and holding owners firmly to agreed dates and deliverables.Maintain program risks, dependencies, verification/validation needs, and engineering evidence required for design history and regulatory submissions.Track cost, schedule, and risk for each program; identify slippage early, force recovery plans, and escalate unresolved blockers before they affect critical milestones.Guide execution of existing product improvements and future hardware, assay, and software-enabled diagnostic products as the portfolio evolves.Support assay and reagent teams to ensure analytical performance is sufficiently characterized from R&D through manufacturing scale.Work with Software, Data Science, and AI teams to ensure digital components are developed, tested, and documented appropriately for the product and regulatory context.Oversee software development following appropriate SDLC and medical-device documentation practices.Drive design for manufacturability, reliability, and usability across reader, mechanical, consumable, and packaging development.Partner with QA/RA on CE-IVDR and future regulatory submissions. QA/RA owns the QMS and dossier assembly; the Program Manager owns driving engineering teams to generate complete, timely, defensible evidence and close gaps.Expected OutcomesDelivery of product lifecycle and new-product programs meeting analytical, usability, manufacturing, schedule, and regulatory goals.Predictable execution across assay, hardware, software/data, manufacturing, and quality workstreams, with clear owners and aggressive follow-through on dates.Complete, traceable engineering evidence that enables QA/RA to maintain audit-ready design files and prepare regulatory dossiers.Establishment of a reusable program framework that accelerates future product improvements and adjacent diagnostic launches.Candidate Profile5+ years managing regulated product development in IVD, medical devices, connected diagnostics, or similarly complex engineering products.Strong knowledge of design control, risk management, verification/validation, and regulatory readiness; direct IVDR experience is useful but not mandatory.Technical fluency across multiple relevant domains such as diagnostics/assays, electronics, mechanical systems, software, imaging, or data-driven products.Experience leading multi-site R&D teams with strong communication and execution discipline.Demonstrated ability to hold technical teams accountable to aggressive timelines - pushing for specificity, challenging weak commitments, and escalating blockers early rather than passively reporting status.Comfort operating in a fast-paced, startup-style environment with minimal hierarchy.