Overview An innovative organisation operating within the pharmaceutical and drug delivery device sector is seeking a Senior Device Engineer to support the development, testing and evaluation of drug delivery systems and associated components. This role sits within a multidisciplinary engineering and scientific environment and will focus on generating technical evidence to support device development programmes through testing, analysis, risk assessment and design verification activities. The successful candidate will contribute to robust and compliant product development by applying engineering principles, analytical techniques and data-driven decision making. Key Responsibilities
- Work within cross-functional teams to identify and investigate critical device performance characteristics.
- Support the creation, review, and maintenance of design control documentation.
- Contribute to design assessments, design verification activities, and manufacturing process qualification programmes.
- Develop and execute test methods, experimental rigs and bespoke test setups.
- Support early-stage usability studies and user requirement gathering activities.
- Assess supplier designs to identify critical functional requirements, potential failure modes, and design sensitivities.
- Participate in risk management activities including design and use-related risk assessments.
- Apply engineering, scientific, and statistical principles to solve technical challenges and support project decisions.
- Analyse data using appropriate analytical and statistical techniques to evaluate device performance.
- Design and execute experimental studies, including Design of Experiments (DoE) methodologies.
- Operate laboratory equipment in accordance with established procedures and quality standards.
- Support documentation associated with regulated environments, including change control, equipment compliance, troubleshooting, and inventory activities.
- Manage experimental data, ensuring accurate recording, verification, and analysis.
- Prepare clear technical reports and summaries of experimental findings.
Required Experience
- Degree, HND or equivalent qualification in an Engineering or Scientific discipline.
- Experience working across the medical device or drug delivery device development lifecycle.
- Knowledge of mechanical and/or electronic testing methodologies.
- Experience supporting development, troubleshooting or optimisation of products, processes, or analytical methods.
- Understanding of risk management approaches and engineering problem-solving techniques.
- Experience interpreting and analysing technical data to support development decisions.
- Strong technical report writing and documentation skills.
Desirable Experience
- Test method development and validation.
- Experience with design verification activities.
- Knowledge of specification development and setting.
- Familiarity with stability or transportation studies.
- Understanding of regulated environments such as pharmaceutical or medical device industries.
- Experience using CAD software (ideally Creo or similar).
- Knowledge of engineering calculations and mechanical analysis.
- Experience with scientific testing equipment and laboratory-based investigations.
- Awareness of FMEA methodologies.
- Knowledge of FEA (Finite Element Analysis).
- Understanding of GMP, GLP or ISO 13485 environments.
Key Skills & Attributes
- Strong analytical and problem-solving ability.
- Logical, methodical, and detail-oriented approach.
- Ability to work independently while contributing effectively within multidisciplinary teams.
- Excellent written and verbal communication skills.
- Strong organisational and prioritisation skills.
- Comfortable working to project deadlines.
- Proactive approach with a willingness to take ownership of tasks.
- High standards of accuracy and data integrity.
Suitable Backgrounds
- This opportunity could suit candidates from:
- Medical Devices
- Pharmaceutical Engineering
- Drug Delivery Devices
- Product Development Engineering
- Device Verification & Validation
- Mechanical Testing & Analysis
- R&D Engineering
- Design Assurance
- Human Factors / Usability Engineering
- Laboratory Development & Testing