Medical Device Programme Lead

I'm working with a specialist life sciences organisation that is looking to appoint a Medical Device Programme Lead to take ownership of a late stage drug device combination programme.

This is a hands-on programme leadership role with real responsibility.

You’ll work closely with clinical, regulatory, quality, manufacturing, procurement and finance teams and report directly to the Chief Solutions Officer.

What you'll be doing:

• Own the medical device programme across timelines, risks, decisions and delivery.
• Manage external design and manufacturing partners, holding them accountable for deliverables.
• Review and challenge technical documentation, protocols, reports and risk analyses.
• Manage device development alongside clinical and regulatory timelines.
• Oversee builds, yields, component lead times, ordering and clinical supply.
• Own the device budget alongside Procurement and Finance.
• Maintain oversight of the Design History File, design traceability and V&V.
• Support combination product submissions and regulatory responses.
• Ensure devices, kits, labelling and shipping are ready for clinical sites.
• Support IFUs, surgeon training and technical dosing requirements.
• Work with Quality and Pharmacovigilance on device deficiencies, investigations and CAPAs.
• Oversee software lifecycle and cybersecurity where relevant.

The experience they're looking for:

• Experience leading medical device programmes within a small sponsor, with broad ownership and limited internal support.
• Strong experience with infusion, injection or fluid-delivery devices from design control through clinical/commercial use.
• Proven experience managing external design and manufacturing partners.
• Experience supporting devices through interventional clinical trials.
• Understanding of manufacturing builds, lot planning, yield, lead times, tooling and process validation.
• Strong knowledge of ISO 13485, ISO 14971, design controls and combination product requirements across US/EU frameworks.
• Comfortable owning programmes where delivery is largely outsourced.
• Degree in engineering, computer science, life sciences or equivalent experience.

Nice to have:

• SaMD / IEC 62304
• Surgical planning, navigation or connected devices
• AI/model-enabled medical devices
• Neurosurgical or neurological delivery
• Stereotactic, intraparenchymal, intrathecal or intraocular delivery
• Gene, cell or other advanced therapy programmes