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Associate Principal Engineer - Quality Management System

Summary

Salary
Competitive
Team
Design and Development
Location
United Kingdom - Malmesbury Office

About Dyson

Dyson product development is dynamic and innovative. Our products are built to last, as well as perform. To achieve this in fast paced consumer markets, we need to focus on both the efficiency and quality of our product development processes. The Product Development Architecture team work with representatives from global teams across the company to relentlessly improve everything we do. And with so many new categories on the way, our team needs to be more effective than ever. This team plays a vital role in supporting Dyson’s future technology. The team is split into a number of different practices that focus on specific areas based on knowledge and skills, these include, Strategic architecture, Change & Transformation, of core engineering processes and departmental governance.

About the role

This Associate Principal role within the central Business Process team of RDD will be working very closely with the Quality team to apply knowledge and experience of medical quality engineering principles and methods to ensure Dyson processes are compliant with regulatory requirements and Dyson’s systems/procedures to optimize product development, internal and external device engineering & manufacturing,

The role primarily concerns developing and implementing across RDD a QMS to achieve ISO13485 certification and enable successful FDA 21 CFR part 820 regulatory approval. 

  • Working as a bridge between the Quality team and all RDD teams to understand and shape our QMS strategy and design development processes.

  • Helping to form and become a member of Working Group structure, as necessary, to provide guidance and decision making for major departmental projects and processes.

  • You will be engaging with 3rd party external consultants to provide a blend and balance of internal and external knowledge and solutions.

  • Providing expert technical supervision & guidance to global engineering teams.

  • Supported by a team of Technical and Business Analysts, enabling them to deliver improvement activity, on time and on "benefit".

About you

  • Enable advancement of our engineering capability in terms of QMS & regulatory compliant processes.

  • Find and evaluate opportunities for optimisation within all the mechanical and electronics areas (Hardware, Software & Connectivity), utilising internal and external resources as appropriate.

  • Develop our ability to identify process problems and their root cause, and to improve fixes quickly.

  • Develop Solutions by conducting ‘design/build/test’ cycles for processes, tools, techniques which optimise product development.

  • Embed improvements effectively within operational teams to deliver measurable benefits

  • Build and maintain relationships with key stakeholders across RDD including representatives from Quality and IT Teams, Process Owners, Technical Training, and Business analytics teams.

Background & Experience:

  • A Bachelor's Degree or equivalent in in Engineering or Scientific field.

  • Demonstrable experience (minimum 6 years) and proven track record in implementation or maintaining of QMS across a design and development function.

  • Demonstrable deep understanding of QMS and relevant ISO standards (including ISO 13485, ISO 14971, ISO 62366 and ISO 60601) and FDA regulations.

  • Hands-on and deep experience of at least four of the following seven core design controls areas:

  • 1) Design Inputs, Insights & Requirements Management

  • 2) System Engineering

  • 3) Risk Management

  • 4) Bug, Issue & CAPA Management

  • 5) Release and Change Management

  • 6) Verification & Validation Management

  • 7) Clinical Trail Management

  • A successful track record of robust design delivery within a product development industry.

  • In-depth technical knowledge and understanding of core engineering best practice.

  • Desirable to have working knowledge of Software development or IoT integrated development.

Core Skills

  • Excellent business analysis and problem-solving skills.

  • Excellent Project/Programme Management skills.

Attitude

  • Ability to drive business change through influencing business leaders using sound communication and collaborative decision-making skills.

  • The willingness to challenge assumptions and ability to adapt or generate imaginative and innovative ideas to drive productivity.

  • Set high goals for self and others, focusing on the delivery of targets and high quality.

Process Owner & Stakeholder Collaboration:

  • Identifying and assessing improvement areas & future strategy within the processes we own.

  • Ensuring that the processes and solutions meet the global requirements of the business.

  • Incorporating industry leading practices into the tools, processes, and/or systems as appropriate.

Process Improvement:

  • Leading scoping and delivery of transformation activities using process improvement tools and engineering knowledge.

  • Conducting project management best practices, including stakeholder, risk and change management responsibilities.

  • Leading process design workshops/activities with relevant senior sponsors, end user and IT representatives.

  • Conducting pilots to refine any planned updates to tools, processes or systems.

  • Delivering deployment activities for any process and/or system changes.

Process Adherence:

  • Working with the Business analytics team to capture and analyse KPIs that assess process performance & adherence

  • Capturing and communicating benefits delivered by improvement activities

User Support & Training:

  • Working with the Technical Training team, to develop and support delivery of training.

  • Providing end user support to maximise business adoption of deployed tools, processes and systems.

Benefits

Financial:

  • Performance related bonus

  • Company paid Life Assurance

  • Discounts on Dyson machines

  • Competitive pension scheme

  • Purchase additional holidays 

Lifestyle:

  • 27 days holiday plus statutory bank holidays

  • Free bus travel to and from Malmesbury campus from Bristol, Chippenham and Swindon

  • On-site parking

  • Endless free coffee and tea, and a free lunch 

  • Free on-site hair salon

  • On-site lifestyle Assist

  • Electric vehicle scheme 

Health:

  • Private Medical insurance for all employees

  • Employee Assistance Program for employee and dependants

  • Digital GP and prescription service

  • Fertility treatment support

  • On-site gym and sports centre

  • On-site wellbeing centre

#LI-DYSON


Dyson is an equal opportunity employer. We know that great minds don’t think alike, and it takes all kinds of minds to make our technology so unique. We welcome applications from all backgrounds and employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other any other dimension of diversity.

Interview guidance

We are following the government guidelines regarding COVID19. At this time all interviews will be conducted via video or telephone. We’re taking these precautionary measures to protect both our employee and candidate wellbeing. Our Talent Acquisition team will work with you and provide further information as appropriate.