Senior Device Development Engineer

SMC Pharma Services Ltd is seeking an experienced design engineer to join our small but growing Device Development team working on our range of autoinjector platforms. The main purpose of the role will be to lead device development programmes that meet the necessary functional performance, manufacturability and commercial requirements, whilst adhering to regulatory standards, according to development timescales and costs that meet business plans and needs.

This role will work collaboratively with human factors engineers, quality assurance, and manufacturing teams to ensure successful product development and commercialization.

We are particularly keen to hear from candidates with experience of compliance with relevant standards for combination product and/or regulatory submission.

• Supporting the technical leadership of the design and development of drug delivery devices from concept to commercialisation. This includes:
• Identification and protection of IP
• Ensuring engineering specifications meet customer needs, align with regulatory expectations and are suitable for verification and validation.
• Appraisal of designs to ensure that functional performance is achieved, manufacturability is robust and regulatory standards are met
• Design Control - Ensure that all project inputs and outputs are thoroughly documented, providing a robust and detailed design history file for device developments, acting as a role model for other members of staff in terms of the quality of documentation produced.
• Represent the company at external events, providing presentations and articles for publication.

• Preparation and implementation of test plans to demonstrate performance, reliability, and safety of drug delivery devices.
• Supplier Management - Assess, select and work closely with suppliers to select components, ensure quality, and manage the manufacturing of drug delivery devices.
• Represent the company in customer meetings as required.

• Ensure that all device development activities are compliant with relevant regulatory standards, such as ISO 13485 and FDA regulations. Collaborate with client regulatory affairs teams to support submissions.

• Experience in design and development of drug delivery systems
• A strong background in design, development and validation of injection moulded components
• Experience in the development of intricate but robust mechanisms
• Experience in risk assessment and risk management.
• Experience in working with customers.
• Skilled in the use of CAD tools, ideally Solid Works
• Experience of US and EU regulatory requirements for drug delivery systems

Some ad hoc travel may be required with this role within Europe and the US.

We offer a competitive salary and benefits package, and the opportunity to work flexibly.