To lead work packages within device development programmes that meet the functional performance, manufacturability and commercial requirements, whilst adhering to regulatory standards, according to development timescales and costs that meet business plans and needs.
- Technical owner of work streams within the development of parenteral drug delivery systems from concept design to commercial prototypes as required by the project plan.
- Manage day-to-day activities of one or two engineers including full-time Oval employees e.g. apprentices or placement students and oversee the work of contractors and external organisations.
- Complete the risk management activities to meet project timescales, device performance and quality requirements.
- Provide the necessary technical leadership to identify any changes to concept designs necessary to ensure that both functional performance and regulatory standards are met.
- 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.
- Work closely with both the Oval and SMC industrialisation teams to ensure appropriate manufacturing processes are developed alongside detailed device designs.
- Identify resource requirements for project activities and contribute to the budgeting process.
- Act as a project team member for customer projects as required.
- Represent the company at external events, providing presentations and articles for publication.
- Identify potential for IP and review applications as required.
- Comply with policies, procedures and guidelines in line with ISO13485 and any other applicable regulations.
Experience/Skills needed to fulfil the role
- Experienced in design and development of drug delivery systems.
- Strong background in design, development and validation of injection moulded components.
- Experienced in the development of intricate but robust mechanisms.
- Experienced in risk assessment and risk management.
- Experienced in working with customers.
- Skilled in the use of CAD tools, ideally SolidWorks
- Experience of US and EU regulatory requirements for drug delivery systems.
- Degree or equivalent in mechanical engineering or other related subject e.g. bio-medical engineering.