Project Engineer - Medical Devices
Project Engineer - Medical Devices
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Job Description
POSITION SUMMARY
This position is in the Biotherapeutics (BTx) Pharmaceutical Research and Development Devices Centre of Excellence (DCoE) located in Cambridge UK.
The incumbent will provide project engineering support to DCoE Line Management and Device Development Leaders in the development and industrialisation of drug delivery devices and life cycle management activities working with multiple stakeholders from differing groups
Collaboration with colleagues across Pfizers global network and with external vendors is key to successful deliverables
POSITION RESPONSIBILITIES
Manage plan and coordinate specific project activities to meet specified targets for quality cost and schedule as defined by the DDL for assigned projects
Create and execute detailed industrialisation project plans
Identify scope create and execute technical agreements with Parties external to DCoE for the effective production and transfer of materials
Understand and manage the potential cost and schedule impact of material import and export
Collaborate with PGS Teams / Global External Supply / Third Party Vendors to implement manufacturing capability for device programmes at clinical and commercial scale
Support continuous improvement activities across DCoE for both product and processes
Actively contribute to risk management processes including dFMEA uFMEA and pFMEA
Support design and validation reviews both internally and with suppliers
ORGANIZATIONAL RELATIONSHIPS
Device Development Project Teams
BTx PhRD
QA and GCMC
PGS nominated sites
External Vendors
EDUCATION SKILLS AND EXPERIENCE
Degree HND or equivalent in relevant engineering discipline
Proven experience of MDCP development.
familiarity with principles of device design control considered beneficial.
Able to demonstrate practical analytical and pragmatic approach to work
Capable of both working in a team and independently
Background of working in teams in the development or trouble shooting of devices analytical methodology or manufacturing processes by means of designed experiments and logical problem solving.
Able to communicate clearly and concisely with internal and external team members in an appropriate oral
and/or written format
Able to articulates ideas and concepts clearly to all levels and technical abilities
Able to learn and understand new concepts quickly
Able to learn and apply established procedures in a reliable and consistent manner
Capable of seeing the wider implications of technical decisions
Excellent standard of written and spoken English and numeracy
Ability to plan organise and prioritise own work with minimal supervision
Comfortable working to agreed deadlines
TECHNICAL SKILLS REQUIREMENTS
Proven experience of mechanical product or production engineering
Knowledge of equipment validation
Knowledge of injection molding
Knowledge of automated equipment for assembly and/or testing
Knowledge of using risk assessment tools including FMEA
Knowledge of ISO13485 / Principles of Design Control
Experience with Supply Chain principles (practice or theory)
PHYSICAL POSITION REQUIREMENTS
Must be able and willing to travel globally in support of project requirements
May be required to travel at weekends
May be required to be away from home for a period of up to two weeks
Must be able to drive
Closing Statement
This position holds a UK Grade 08.
The closing deadline for applications is end of day April 30th.
All applicants must have the relevant authorisation to live and work in the UK.
Work Location Assignment:On Premise
Purpose
Breakthroughs that change patients lives... At Pfizer we are apatient 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 start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer Pfizer iscommitted to celebratingthisin all itsforms allowing for us to be as diverse as the patients and communities we serve. Together we continue to build a culture that encourages supports and empowers our employees.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people especially those with unique superpowers. Your journey with Pfizer starts here!
Research and DevelopmentEmployment Type
Full-Time
