Medical Device Development​/Design Engineer

Prorenata Biotech is a Qatar-based biotech company developing GENO
, a first-in-class platform that enables on-demand, point-of-care manufacturing of gene therapy nanomedicines. GENO is designed to move advanced genetic medicines out of centralized mega-factories and into clinical and research settings.

We are now advancing GENO from a validated prototype into a GMP-ready, manufacturable, and regulatory-aligned device platform
, working closely with academic, clinical, and industrial partners.

We are hiring a Lead Device Development / Design Engineer to take technical ownership of the GENO device.

This is a hands-on, high-responsibility role for an engineer who wants to build, decide, and ship a real medical device. You will own the engineering evolution of the device from design optimization through pilot manufacturing, while embedding quality‑by‑design principles from the start.

This is not a paperwork‑only QA role and not a maintenance position.

• Own Device Development
• Lead the end-to-end engineering and design evolution of the GENO device from prototype to pilot‑ready system.
• Design for Compliance
• Embed quality‑by‑design principles into the product architecture to ensure downstream regulatory readiness.
• Plan and support device verification and preclinical validation activities in collaboration with research partners.
• Manufacturing Transfer
• Work directly with external manufacturers to enable DFM/DFS, pilot builds, and technical handoff.
• Technical Documentation
• Generate clear, traceable engineering documentation supporting DHF/DMR and future regulatory submissions.

• Degree in Mechanical or Biomedical Engineering (Master’s preferred).
• Proven Builder
• 3–5+ years of hands‑on experience developing physical medical or lab devices (non electrical) beyond the research stage.
• Validation Mindset
• Experience with hands‑on testing, verification, and iteration of real hardware.
• Quality‑Aware Thinking
• Working knowledge of design controls, risk management, and ISO 13485‑style thinking (not just paperwork).
• Ability to write concise, structured technical documentation and explain design decisions clearly.
• Location Ready
• Available to work on‑site in Doha, Qatar.

• Experience with microfluidic
  , cartridge‑based, or drug delivery systems
• Exposure to LNPs, mRNA, gene therapy
  , or related translational platforms
• Prior involvement in FDA 510(k), CE marking
  , or equivalent regulatory pathways
• Startup or early‑stage product development experience
• Contributions to patents or publications in medical devices

• True Ownership of a core, first‑in‑class medical device platform
• Direct Access to Decision‑Making
  , working closely with the founder
• High Autonomy with responsibility for outcomes, not just tasks
• Clear Path to Technical Leadership as the company scales
• End‑to‑End Exposure to design, validation, manufacturing, and regulatory readiness
• Technical Credibility
  , with your work forming the basis of validation studies and regulatory dossiers
• A focused, builder‑driven culture that values rigor and execution