Design Assurance Engineer - Junior/Senior

Job Summary

Are you passionate about making a difference to patients’ lives? Do you want to build a strong career within a company that excels in delivering high quality research? Why not let our client realise your potential? Join one of the most successful, internationally recognised and established clinical teams in the industry.

Company Statement

Our client is one of the largest, most reputable clinical research orginisation who research, develop, manufacture and market their own products. They are a pioneer in leading edge research in drug trials and medical devices, they bring novel therapies to improve quality of patients’ lives around the world!

Responsibilities

• Provide Design Assurance input to R&D project teams .  
• Understanding the Regulatory requirements for device developments 
• Participate in the generation of Design Input / Output documents. 
• Drive the risk management activities for designated projects 
• Design, development and validation of test methods 
• Develop and maintain design verification and validation plans, protocols and reports.
•  Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, MDR 2017/745, FDA Quality System Regulations 21 CFR Part 820, FDA GLP Regulation 21 CFR 58, ISO 13485, ISO 14971, Japanese Ministerial Ordinance # 169. 

Qualifications

• A degree level qualification in Engineering, Science, QA or related field is required
• A minimum of five/three years’ relevant experience in the medical device or pharmaceutical industry
• Experience with Stent and Stent Coating technology experience. 
• An understanding of ISO 13485, ISO 14971 and FDA QSRs is a prerequisite. 
• Familiarity with statistics, validation and physical testing is required. 
• Good communication and organizational skills,
• The ability to present reports neatly and accurately is essential. 
• Experience in DES is an advantage 

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age