Description

This is a full time, permanent position. Working a flexible 37 hour week, Monday – Friday.

The purpose of this job within the Device Engineering group is to support the human factors engineering activities for assigned medical devices and combination products (MDCPs) from concept to regulatory approval in all intended markets, and will interact with cross functional development teams, working with all levels of employees.

Job Responsibilities:

• Lead human factors engineering activities for assigned MDCP programs, ensuring deliverables are appropriately authored, approved, and maintained to support clinical trials and commercial licensures.
• Provide usability input/support to MDCP design inputs and design specifications
• Author, manage, approve and maintain support for use related risk management activities related to assigned MDCPs
• Assist with all design validation activities for assigned projects including clinical study support, complaints analysis and author use related risk assessments/justifications for not performing human factors where applicable.
• Support all human factors (HF) activities associated with HF vendors, including on-boarding of HF vendor, generation of study brief, attainment of HF vendor proposals, assignment of HF vendor, providing all relevant materials and documentation, management of HF studies, and generation and approval of associated reports
• Support project management of the supply, assembly and testing of materials for use in HF studies and associated documentation, ensuring timely execution of HF studies for assigned projects
• Provide HF study feedback and/or recommended mitigation actions into the relevant project team and external device design authorities where appropriate
• Provide input and support for generation of assigned device Instructions for Use (IFU), MDCP labelling and packaging
• Design and ensure full change control for IFU documentation where applicable for assigned projects
• Support the generation of device regulatory submission data and content for assigned MDCP projects
• Support and conduct human factors research to augment present and future MDCP projects including inhouse laboratory testing and external research with the support of contract staff/vendors
• Support continuous improvement activities as they relate to design validation/human factors
• Support MDCP design and manufacturing investigations from devices used in clinical trials and commercial manufacture.
• Support internal and external audits of the DCoE, DPDD and GT&E Quality Systems (as appropriate) as they relate to design validation/human factors.
• Identify, communicate, and develop strategies to improve combination product systems.
• Provide guidance and act as mentor to junior colleagues in the team.

Qualifications

• Hold either a BSc, MSc or PhD in an appropriate science & engineering discipline (chemistry, biology, biomedical sciences, mechanical
• History of working in accordance with the requirements of ISO 9001, ISO 13485, ISO62366, ISO 14971, 21 CFR 820, 21 CFR Part 4, ISO 11040 and the EU Medical Devices Directive.
• Proficient in design controls and risk management for combination products.
• Expertise with Human Factors Engineering - Usability Engineering.
• Understand project management methodologies and capable to provide technical leadership for projects.
• Good understanding of device assembly manufacturing processes.
• Thorough working knowledge of ISO 9001
• Able to learn and apply established procedures in a reliable and consistent manner.
• Capable of working independently with minimal supervision.
• High level of attention to technical details and accuracy.
• Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
• Able to work collaboratively in cross functional teams.
• Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.
• Proficiency in general computer software such as word processing, spreadsheets, presentations.
• Understand Good Manufacturing Practices (GMP).

Additional Info

At Eurofins we are growing, innovating and always learning. We celebrate the achievements of our employees through annual long service awards, recognise our colleagues special life events, and we are committed to charitable causes through global fundraising activities.

As a Eurofins employee you will benefit from:

• Reward and Recognition
• Health Cash Plan
• Life Assurance (4 times annual salary).
• Company Pension Plan
• Employee Assistance Programme – 24/7 confidential support.
• Free car parking
• Worldwide career opportunities
• Everyone who joins our team also gets access to Perkbox, allowing you to save money all year round. Whether its supermarket savings or days out, the daily coffee or a summer holiday – there’s something to suit everyone’s lifestyle.

What Happens Next

Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths. 
 
Your data 
As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
 
We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique.

Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal!

Find out more in our career page: https://careers.eurofins.com/ 

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate.

Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies.

Eurofins PSS Insourcing Solutions® is a global, award-winning insourcing solution. We place our skilled team directly at the client site, managing operations seamlessly and eliminating complexities. We ensure a strategic, long-term service commitment that delivers value directly at the client’ site, utilising their facilities, equipment, and methodologies, while maintaining the same service, expertise, and cGMP compliance available at the Eurofins facility. If you're an employee seeking an exceptional career journey, Eurofins PSS Insourcing Solutions® is your gateway to a future where innovation, collaboration, and success converge. Join us in a world where excellence knows no boundaries!

We’re proud to be an armed forces-friendly place to work and welcome applications from reservists, armed forces veterans (including the wounded, injured and sick), as well as cadet instructors, and military spouses and partners.

If you want to continue to help make our world a safer and healthier place, then apply for the role below and become a part of the extraordinary Eurofins network