Be a part of a global team where what we do matters! At Epredia, we recognize that our talented employees are vital to our success. Our team is dedicated, our work is rewarding – both personally and professionally – because what we do matters. 

　　We seek talented individuals who will contribute to and thrive in our collaborative, diverse, fast-paced environment while demonstrating a commitment to our core values, People, Customer, Results, Continuous Learning, and Innovation. 

　　People – We win as a team. 

　　Customer – We deliver customer-centric solutions. 

　　Continuous Learning – We learn and always aim to be better. 

　　Innovation – We innovate every day. 

　　Results – Results matter for all of us.

　　As the Senior Engineer for Design Controls and Technical Compliance, you will manage the procedures covering all phases of the R&D lifecycle, including Product Development Process (PDP), also referred to as Design Controls. You will develop and maintain the design management process employed by R&D teams located in Europe, China and the US. You will also collaborate cross functionally with teams outside of R&D and gain wider business exposure. With a diverse product portfolio which covers consumables and capital devices, including devices for both anatomical and digital pathology, the role will be engaging and challenging presenting you with excellent opportunities to develop and grow. It is an exciting opportunity to set global standards in Epredia and become a key point of contact we can rely on! This is a hybrid position where you would occasionally work from our Runcorn office (approximately one week per month depending on business needs, it could be less or more).

　　Essential Job Functions and Accountabilities:

　　Design Controls:

　　Develops and maintains the R&D Procedures ensuring conformance to regulatory and industry standards

　　Creates training materials and delivers training to all staff interacting with the R&D processes

　　Collaborates with QA departments and R&D managers to ensure R&D documentation is in compliance with R&D Procedures

　　Technical Compliance:

　　Monitors trends in the global environmental and safety regulations for products

　　Identifies compliance threats and ensures mitigations,

　　Ensures that compliance to all applicable regulations, standards are maintained and evidenced.

　　Co-ordinates and implements process improvements,

　　Co-ordinates and implements Continuous Improvement activities to establish and reinforce a culture of design excellence within the R&D teams

　　Essential Qualifications/Skills:

　　BSc degree in a relevant discipline e.g. (Mechanical, Electronics, Software Engineering)

　　Understands and is driven by the industry requirements for IVDR/Medical Devices,

　　In depth knowledge of 21 CFR 820, 21 CFR 11 and ISO 13485 associated with the medical device industry,

　　In depth knowledge of environmental requirements including, but not limited to, OSHA GHS, RoHS, REACH CLP.

　　Understanding and experience with Design Controls,

　　Experience in Product Development projects.

　　TO ALL RECRUITMENT AGENCIES: Epredia does not accept unsolicited third-party resumes.

　　Building an Inclusive Culture: We are a company that brings varying backgrounds, ideas, and points of view to inventing on behalf of all customers. Our diverse perspectives are enriched by many dimensions, including race, ethnicity, gender, age, physical and mental ability, sexual orientation, religious beliefs, culture, language, and education, as well as professional and life experience. We are committed to diversity, equity, and inclusion, and leveraging our unique perspectives to scale our impact and growth.

　　At Epredia, we improve lives by enabling better cancer diagnostics. We are a team of talented individuals with diverse backgrounds and expertise, working together to develop precision diagnostic solutions for our customers. We are a fast growing global company that drives innovation in diagnostics to create better outcomes for patients. Joining Epredia is much more than a job- it is an opportunity to be part of something with a purpose. Find out how you can improve lives while advancing your career.