Job Title: Senior Associate Device Engineer - Grade VI

Location: Cambridge, UK
Duration: 12 Months
WorkType: Onsite

Overview

TekWissen is a global workforce management provider throughout the UK, Europe, and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation.

Job Description

To provide technical project support within the Device Engineering Sciences team through the testing, analysis, and evaluation of novel drug delivery devices, components, and primary containers (e.g. syringes and cartridges).

The role is responsible for risk assessment and mitigation, including execution and analysis of experimental work in accordance with established SOPs and quality standards.

The individual will act as a Subject Matter Expert in device development, applying their knowledge of specification setting, problem solving, engineering assessment, analytical method development, and design verification to support robust, compliant, and data-driven device development activities.

Important qualities include the ability to work accurately and within agreed deadlines and in compliance with established working practices.

Major Duties

• Work as part of a multidisciplinary team to determine what performance factors of the drug delivery device will require assessment and investigation.
• Support Design Engineering Science project lead with authoring, review, and management of design control documentation.
• Support interactions with external vendors and internal partners within the following activities: design assessment, design verification, and manufacturing process qualification for drug delivery devices.
• Support design and development of test methods, experimental rigs, and test setups.
• Support early-stage usability and market research studies to identify user requirements.
• Design test rigs and challenge parts.
• Assess supplier designs and strategies to identify critical to function areas, likely failure modes, and design sensitivities.
• Risk management assessment and mitigation, including input to dFMEA and uFMEA.
• Application of statistical, scientific, and engineering expertise and research experience to solve problems creatively and independently and support decision making.
• Use of analytical and statistical tools to analyze the data in order to quantify the functional performance characteristics of the device, the controlling parameters for its consistent performance, etc.
• Define appropriate approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
• Operate laboratory equipment according to SOPs, Manuals, Methods, and Risk assessments etc.
• Responsible for a wide variety of ISO 13485 related documentation and laboratory tasks including change control, instrument managing instrument compliance, inventory control, and troubleshooting as needed.
• Responsible for data management including transcription, verification, and analysis of testing results.
• Prepare scientific reports of experiment, data analysis, and data verification in accordance with approved procedures and practices.
• Perform other duties as assigned in support of business goals.