Control Design Engineer

1 week ago


North East, United Kingdom Kinetica Full time

Kinetica, Tyne And Wear, England, United Kingdom Base pay range Direct message the job poster from Kinetica About the Company We are looking for a quality professional with extensive experience in compliance for product development and design control, to work for a leading diagnostics company. This is a fully site-based role within a newly formed team. Responsibilities Support site projects that drive new product development (NPD) and product lifecycle management (PLCM). Provide Design Control leadership and collaborate across LBS and Danaher sites. Improve processes to reduce variability and strengthen product robustness. Lead functional teams or medium-scale projects as needed. Partner with Regulatory Affairs on global submissions, including FDA 510(k), PMA, and IVDR CE documentation. Requirements Strong knowledge of Design Controls and design/development practices for medical device or diagnostic products. Extensive experience in medical device development and quality systems. Expert understanding of standards such as 21 CFR 820, ISO 13485, ISO 14971, and MDSAP. Proven Quality leadership experience. Bachelor’s degree in a scientific, or technical discipline. Seniority level Not Applicable Employment type Full-time Job function Quality Assurance and Research Industries Medical Equipment Manufacturing Measuring and Control Instrument Manufacturing Biotechnology Research Referrals increase your chances of interviewing at Kinetica by 2x. #J-18808-Ljbffr


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