Senior Associate Device Engineer

Job Overview

We are seeking a hands-on Senior Associate Device Engineer to provide technical project support across the testing, analysis and evaluation of innovative drug delivery devices, components and primary containers, including syringes and cartridges.

Working within a multidisciplinary engineering and scientific environment, you will support device development activities spanning design assessment, specification setting, test method development, design verification and risk management.

The role requires strong practical engineering and laboratory experience, with the ability to develop test methods and experimental setups, analyse device performance data and produce accurate technical documentation in accordance with established quality standards and procedures.

Responsibilities

• Work within multidisciplinary teams to identify and assess critical performance characteristics of drug delivery devices.
• Support the preparation, review and management of design control documentation.
• Support design assessments, design verification activities and manufacturing process qualification.
• Develop test methods, experimental rigs, fixtures, challenge parts and test setups.
• Conduct mechanical and/or electronic testing of drug delivery devices and components.
• Support early-stage usability and market research activities to help identify user requirements.
• Assess supplier designs and technical strategies to identify critical-to-function areas, potential failure modes and design sensitivities.
• Contribute to device risk assessments and mitigation activities, including dFMEA and uFMEA.
• Apply scientific, statistical and engineering principles to solve technical problems and support evidence-based decision-making.
• Use analytical and statistical tools to evaluate device performance and identify parameters affecting consistent functionality.
• Apply Design of Experiments methodologies and statistically interpret experimental data.
• Operate laboratory and scientific testing equipment in accordance with SOPs, approved methods, manuals and risk assessments.
• Support ISO 13485-related activities, including change control, equipment compliance, inventory management and technical troubleshooting.
• Maintain accurate testing records and complete data transcription, verification and analysis activities.
• Prepare clear scientific and technical reports covering experimental activities, results, data analysis and verification.
• Collaborate with internal engineering, quality, regulatory, compliance, human factors and scientific teams, as well as external suppliers and partners.

Requirements

• Degree, HND or equivalent qualification in Mechanical Engineering, Biomedical Engineering, Medical Engineering, Science or another relevant discipline.
• Previous experience supporting the development, lifecycle management or testing of drug delivery devices or closely related medical devices.
• Good knowledge of mechanical and/or electronic device testing.
• Experience developing or troubleshooting drug delivery devices, analytical methodologies or manufacturing processes.
• Practical experience of experimental testing, structured problem-solving and data analysis.
• Experience supporting design assessment, specification setting and design verification activities.
• Understanding of design controls within a regulated device development environment.
• Experience contributing to device risk management activities, including failure-mode assessment and risk mitigation.
• Ability to develop test rigs, fixtures, experimental setups or challenge components.
• Experience using statistical analysis and Design of Experiments techniques.
• CAD experience, preferably Creo, and familiarity with associated document management systems.
• Understanding of fundamental mechanical engineering calculations, including free-body diagrams, friction and beam bending.
• Experience working with scientific measuring and laboratory testing equipment.
• Strong technical report-writing and data presentation skills.
• Ability to maintain accurate and compliant records in accordance with SOPs and established quality procedures.
• Strong attention to detail with the ability to plan, prioritise and deliver work to agreed deadlines.
• Ability to work independently with limited supervision while contributing effectively within multidisciplinary teams.
• Practical, pragmatic and solutions-focused approach to engineering challenges.

Nice to Have

• Experience within the pharmaceutical, medical device or combination-product industry.
• Hands-on experience with autoinjectors, injection pens, pre-filled syringes, cartridges or other drug delivery systems.
• Experience developing and validating engineering test methods.
• Knowledge of design verification activities, including stability and transportation testing.
• Working knowledge of ISO 13485, GLP, GMP and laboratory safety requirements.
• Experience supporting supplier design assessments or manufacturing process qualification.
• Knowledge of Finite Element Analysis.
• Experience supporting usability engineering or user-requirement activities.