Medical Device Development Engineer 2022

Capable mechanical engineer required to provide engineering analysis and project technical leadership in the medical sector. Working as part of a friendly and motivated team leading the development of drug delivery devices, the role may include tasks from all stages of device development from user requirement capture and due diligence assessment of vendor activities through to validation, trouble-shooting and complaints investigations.

The role requires a combination of technical and planning skills to predict (and mitigate) product risks. You will need to demonstrate an ability to understand the patient and the device whilst balancing project and business requirements. A key requirement for the role is the providing technical leadership within the project to identify, define and resolve product issues and, also, to consider the impact and implications of technical decisions on vendors and on other internal Pfizer groups.

The role is based in the Device Centre of Excellence (DCoE) near Cambridge, UK and may require occasional travel.

Role functions

• Provide technical leadership for the design and development of drug delivery devices
• Manage early-stage usability studies to capture patient capabilities and preferences
• Select design specifications
• Apply theoretical engineering knowledge (e.g. forces, friction, mechanism analysis, materials) to analyse and critique design concepts and solutions, identifying areas critical to function, likely failure modes and design sensitivities, both by hand and using software tools.
• Perform tolerance analysis using RSS or Montecarlo methodology
• Produce viable design solutions in response to specific requirements or specifications
• Produce models and drawings using 3D CAD
  • Modify and develop 3D CAD & drawings from non-native CAD systems
  • Design test rigs and challenge parts
• Perform investigative lab testing to predict design performance and acceptability
• Risk management, assessment and mitigation, including DFMEA, input to UFMEA and assessment of critical functions.
• Support supplier design reviews and Pfizer internal design reviews
• Create documentation to support medical device development and industrialization
• Interact effectively with suppliers and other Pfizer groups

Capabilities and Knowledge

Essential

• CAD (preferably Creo) and associated document management systems
• Engineering calculations eg friction, stress analysis, tolerance analysis
• Experience of using risk assessment tools including FMEA
• Writing clear reports, documents and presentations
• Understanding of quality management systems
• Excellent communication skills with other disciplines
• Critical thinking, problem solving and trouble-shooting

Desirable

• Process Capability Analysis (predictive and actual)
• Experience of user-centred design
• Experience of electro-mechanical systems
• Management of others’ tasks, including managing suppliers
• Experience of plastic components
• Injection moulding

Education and Experience

• Degree or higher in Mechanical Engineering or equivalent
• Experience within the medical device industry would be a benefit, although not essential

Person

• Collaborative
• Practical, analytical, pro-active, pragmatic
• Focussed on the user
• Capable of both working in a team and leading own independent work through to a conclusion
• Communicates well with internal and external team members. Articulates ideas and concepts clearly to all levels and technical abilities
• Able to learn and understand new concepts quickly
• Capable of seeing the wider implications of technical decisions

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility 

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!