Technical Product Manager – Medical Device

Between 65,000€ and 75,000€ gross annual (bonus included)

Company

Hemerion Therapeutics is a clinical-stage health tech company pioneering an interventional oncology platform . Built on over a decade of leading academic and clinical research, Hemerion has advanced well beyond its research origins: our technology has already been evaluated in frontline patients harboring brain cancer through a first-in-human clinical trial, and we are now entering a pivotal study phase, a critical milestone that reflects the maturity and clinical validation of our platform. With an expanding footprint in the United States alongside our European base, Hemerion is scaling its operations to match the ambition of its science. To support our product development and strengthen our technical team, we are recruiting an experienced Technical Product Manager with deep expertise in the full medical device development and industrialization cycle.

DESCRIPTION

We are looking for an experienced Technical Product Manager with a minimum of 10 years of experience to own the full product lifecycle of our innovative medical devices – from initial design through design transfer, subcontractor management, production oversight, and post-market surveillance.

The role covers two distinct and complementary product families: active electro-medical devices and single-use sterile ClassIII medical devices. You will act as the end-to-end owner of the R&D and Industrialization processes, coordinating internal teams and external manufacturing subcontractors, while building the regulatory technical files for both CE marking and FDA submissions. The role also includes hands‑on activities in a lab and production environment (bench testing, batch management).

LOCATION

On-site — Hemerion Therapeutics, 37 rue Denis Papin, 59650 Villeneuve d’Ascq, France (no remote work). Occasional travel to subcontractors and clinical sites is expected.

RESPONSIBILITIES

Under the supervision of the Chief Technical Officer (CTO), you are responsible for the full product lifecycle of our medical device portfolio, from design through to production and technical file submission.

Design & Development

• Design, document, and continuously improve products by integrating clinical needs and regulatory constraints (MDR2017/745, ISO13485, ISO14971, 21CFR820); manage design changes and maintain design history files (DHF) across the full product portfolio;
• Lead and plan all verification and validation (V&V) activities: define and maintain the V&V matrix, write test protocols and reports, conduct in-house optical and mechanical testing, and manage outsourced tests with full analysis and interpretation of results;
• Manage the metrological monitoring of the experimental equipment fleet: calibration scheduling, in-house and outsourced verification, maintenance, equipment labelling, and purchasing of new instruments;
• Conduct technological and scientific monitoring; protect innovation through patent filings and declaration of inventions.
• Manage design transfer to production: maintain and complete Device Master Records (DMR), manufacturing process documents, and process risk analyses (pFMEA) in coordination with manufacturing subcontractors;
• Oversee equipment and process qualification protocols (IQ/OQ/PQ); plan and manage milestones, budgets, and resources for the prototype / pre-series / full‑scale production transition;
• Participate in selecting, qualifying, auditing, and managing subcontractors; maintain proactive communication to ensure quality, timelines, and compliance; handle purchasing and monitoring of supplier orders;

Production

• Oversee sterile device production batches: issue manufacturing orders, manage production follow‑up, complete and maintain Device History Records (DHR), and perform lot release;
• Manage stock control activities: periodic inventory, goods receipt inspections, stock entries/exits, and shipment preparation;

Quality

• Act as R&D and Industrialization process owner: uphold QMS procedures, contribute to management reviews, ensure audit readiness, and maintain associated process risk analyses;
• Take an active role in quality processes: contribution to the QMS, software validation, document management, participation in internal and external audits, and follow‑up of product‑related CAPAs;

Technical file

• Actively contribute to building and maintaining the technical documentation for regulatory submissions, including the CE marking technical file (MDR2017/745) and the FDA submission dossier; act as the operational link with the Regulatory Affairs team to complete all required deliverables (design inputs/outputs, risk management plan and report, usability engineering, substantial equivalence, surveillance plan, etc.).

Qualifications

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