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Austin Vita
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Warrington, Cheshire
Design Validation Specialist
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Salary: £40000.00 - £50000.00 per annum |
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Overview
Design Validation Specialist Austin Vita has been engaged by a leading Medical Devices/In-Vitro Diagnostics business to find the latest addition to the Validation team, a Design Validation Specialist. This is a very exciting time to join the business as they are currently going through a huge period of growth, it would be a fantastic opportunity to be a key element within this process. Overview: You will be expected to make sure that products are delivered to our customers expectations, delivering oustanding performance every time, working alongside multiple teams. Responsibilities: Input into the definition, design, and execution of Product Development activities throughout all phases of the product lifecycle for instruments and consumables. Creates strategies for Performance and Clinical Evaluations and applies risk management principles in the product development incorporating scientific validity of gathered evidence. Working with multimple teams to develop required labelling for NPD Close interaction with customers to get usability and formative evaluation feedback to ongoing product development. Maintaining upto date knowledge of customer workflows Acting as an interface between customers and developers/testers by facilitating the translation of customer needs into product requirements and testing workflows. Qualifications: B.Sc. or M.Sc. in a Life Science related scientific discipline. Minimum of 5 years experience in either the pharma or medical device industry In depth knowledge of 21 CFR 820, 21 CFR 11 and ISO 13485 Extensive hands on experience operating and troubleshooting anatomical pathology instrumentation Ability to create and execute design validation strategy and testing. Ability to execute complex experiments independently, perform in-depth statistical analysis, interpret experimental results, and make sound conclusions. Extensive experience in New Product Launches. Extensive experience in Design Validation activities for US and EU Market introductions Experience with statistic techniques for design validation Experience with ISO14971 and Usability Engineering processes. Ability to critically evaluate proposed study designs with strong knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power. High understanding of GMP, Compliance, Validation Principles including the system development life cycle and IVDR regulatory expectations Adherence to a stage gated quality system. What we offer: Funded private healthcare or health cash plan as preferred Life Assurance policy (4 x basic salary) pension scheme via salary sacrifice Are you a driven Design Validation professional with previous experience in the sector? Then APPLY NOW Design Validation Specialist Austin Fraser is acting as an Employment Agency in relation to this vacancy. Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status. Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants. This job was originally posted as www.totaljobs.com/job/89964387