Product Development Project Engineer-Permanent-Leeds
Recruiter
SidTech
Listed on
25th March 2021
Location
Leeds
Type
Permanent
Start Date
2021-03-25 00:00:00
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What we need. We are looking Product Development Project Engineer. The candidate will work with client & TCS teams to deliver best in-class solutions for medical device product development. Key Responsibilities:Work with cross-functional teams (example: design, development, quality, planning, Regulatory, Post Market surveillance, sterility, Biocompatibility, manufacturing, marketing etc.) across geographies to lead technical file execution.Plan, monitor and execute technical file deliverables efficiently to achieve the project timeline.Review and support product development team for documentation (risk management, FMEAs, design rationale, design control plans, process verification/validation plans/reports, material evaluation reports etc.) for technical files as per the company standards and procedures accuratelyProvide R&D support documentation as required by regulatory for submissions and respond to audit feedback.As and when required, coordinate with design team to get relevant information from drawings & specifications.Provide management with regular status update and work towards resolution of any technical challenges in an efficient mannerCreate/manage Engineering Change Orders and expedite for approvalsAbility to function within a matrix organization and drive collaboration to execute project actions in ambiguous situations, with a sense of urgencyReports issues to the customer and TCS management to ensure appropriate closure Key Skills/Knowledge:Strong relevant experience in Medical Device product development, preferably in Orthopaedics.Understanding of EU MDR (European Medical Device Regulation), FDA, ISO 13485, ISO 14971 requirements for medical devices. Working experience in EU MDR related product development activities is highly preferred.Understanding of various aspects of a Design History File (DHF) for medical device developmentUnderstanding of the Technical File DocumentationExperience in medical device risk assessment techniques, design failure mode effect analysis (DFMEA), design control plans, product complain analysisKnowledge to read and interpret information from Product design documents (CAD models and drawings etc.)Knowledge of PLM change managementProject management experience will be preferredCandidate must be flexible to accommodate additional effort needed to meet project and organizational deadlines.Software skills - Should be proficient with Microsoft Project Plan, PowerPoint, Microsoft Excel Experience Required:Good relevant experience in product development of Medical Devices.Experience in leading and managing project team (Project management Certification is preferred.)Experience/understanding of EU MDR (European Medical Device Regulation) requirementsMedical device risk assessment techniques, design failure mode effect analysis (DFMEA), design control plans, product complain analysisBachelor of Engineering (Mechanical Engineering, Bio-Medical Engineering, Bio-Engineering)Software skills - Should be proficient with Microsoft Project Plan, PowerPoint, Microsoft Excel.Excellent communication and presentation skillShould possess analytical and decision-making skill.Role: Product Development Project Engineer Job Type: Permanent Location: Leeds, United Kingdom
