End-to-End Infusion Device Programme Lead

Barrington James; United Kingdom; On-site; GBP 85,000 - 120,000; Full time

Job summary

Barrington James is seeking an experienced programme leader to take full ownership of an infusion device programme, reporting to the Chief Solutions Officer. You will drive end-to-end activities from design control through to clinical or commercial use, coordinating external design and manufacturing partners and overseeing submissions for US/EU regulatory paths.

You will also own the software side, including SaMD lifecycle and cybersecurity, ensuring tight design history files and traceability

Qualifications

• Infusion, injection or fluid delivery device development from design control to clinical or commercial use.
• Experience working with external design and manufacturing partners.
• Strong knowledge of ISO 13485, ISO 14971 and US/EU combination product requirements.

Responsibilities

• Own end-to-end device programme: plan, budget, risk, decisions.
• Hold design and manufacturing partners to scope; challenge testing and documentation.
• Maintain design history file and traceability.
• Deliver device content for US and EU submissions.
• Coordinate devices, kits and training materials to trial sites on schedule.
• Own the SaMD lifecycle and cybersecurity.

Skills

Device development

External partner mgmt

ISO 13485

ISO 14971

Combination products

Clinical trials supply

SaMD lifecycle

Cybersecurity

Lean startup experience

Job description

Barrington James is seeking an experienced programme leader to take full ownership of an infusion device programme, reporting to the Chief Solutions Officer. You will drive end-to-end activities from design control through to clinical or commercial use, coordinating external design and manufacturing partners and overseeing submissions for US/EU regulatory paths.

You will also own the software side, including SaMD lifecycle and cybersecurity, ensuring tight design history files and traceability