Senior Associate Device Engineer

Are you ready to use your device engineering expertise to help develop the next generation of drug delivery technologies that could improve patient outcomes worldwide?

Proclinical is seeking a Senior Associate Device Engineer to join a dynamic team in the UK. This role focuses on supporting the development and testing of innovative drug delivery devices, including components like syringes and cartridges. You will play a key role in risk assessment, experimental analysis, and ensuring compliance with quality standards. This is an excellent opportunity for someone passionate about engineering and science to contribute to cutting-edge pharmaceutical advancements.

Responsibilities:

• Collaborate with multidisciplinary teams to assess and investigate drug delivery device performance factors.
• Author, review, and manage design control documentation.
• Support interactions with external vendors and internal partners for design assessment, verification, and manufacturing process qualification.
• Develop and validate test methods, experimental rigs, and setups.
• Contribute to early-stage usability and market research studies to identify user requirements.
• Design and evaluate test rigs and challenge parts.
• Assess supplier designs, identify critical areas, and mitigate potential failure modes.
• Conduct risk management activities, including input to dFMEA and uFMEA.
• Apply statistical and engineering expertise to solve problems and support decision-making.
• Analyze data using statistical tools to quantify device performance and controlling parameters.
• Operate laboratory equipment and ensure compliance with SOPs and risk assessments.
• Manage ISO 13485-related documentation, including change control and instrument compliance.
• Prepare scientific reports and ensure accurate data transcription and analysis.
• Perform additional duties as required to support business goals.

Key Skills and Requirements:

• Degree or equivalent qualification in a relevant Science or Engineering discipline.
• Strong knowledge of mechanical and/or electronic testing of drug delivery devices.
• Experience in test method development, validation, and device lifecycle management.
• Familiarity with design assessment, specification setting, and analytical method development.
• Proficiency in CAD software (preferably Creo) and engineering calculations.
• Understanding of GLP/GMP, laboratory safety, and ISO 13485 standards.
• Skilled in using scientific measuring and testing equipment.
• Excellent problem-solving, communication, and organizational skills.
• Ability to work independently and collaboratively within multidisciplinary teams.
• Flexible, adaptable, and detail-oriented with a commitment to quality and excellence.
• Willingness to travel or relocate to the Cambridge area if required.

If you are having difficulty in applying or if you have any questions, please contact Dean Fisher at d.fisher@proclinical.com.

Apply Now:

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