Program Manager – Medical Devices / Diagnostics
The 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 Responsibilities
- Orchestrate 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 Outcomes
- Delivery 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 Profile
- 5+ 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.
