We are looking for a Design Assurance Engineer, to join our Quality Department, based in Bussolengo (Verona), reporting to the Quality Engineering Manager.The role is the liaison between Research Development (RD), Process Engineering and Quality Operation areas, and Regulatory Affairs area, during the Design Development of new products and during business as usual with the primary goal to achieve and maintain product specific validations for attributes such as biocompatibility, sterility, reprocessing and packaging.Additionally the role is expected to :that Design Development activities are conducted in compliance with internal procedures and in conformity with standards, directives and laws applicable to the Organization;closely with RD Area promoting specific activities like Risk Management process, design verification, design validation and final release.Excellent time management and interpersonal relationship skills are necessary in this role.He/she will interact with Consultants, Subsidiaries, Competent Authorities, Notified Bodies, Distributors, External laboratories and suppliers.What will your contribution be?These are related to product aspects such as: sterilization,reprocessing,sterilization andvalidation;and consist of:of validation test plans, protocols, reports and summariesand coordination of internal and external testing activitiesof the existing validations according to international/regulatory requirementAdditional responsibilities are generic to the Quality Engineering Area:Cooperate with internal departments during the Product Development Process to achieve regulatory release (e.g. CE marking, FDA approvals) for new products and product modifications.Manage (i.e. promote, coordinate and document) the Risk Management activities during the Product Development Process, in relation to product modifications and during post-marketing surveillance.Manage (promote, coordinate and document), in cooperation with RD, Marketing, Medical Science and Clinical Affairs, the design validation of new productsPrepare and maintain, as required, Technical File documentation for new products or modified products and cooperate with Regulatory Affairs Area to prepare regulatory submissions, andPrepare and maintain Summary Technical Documentation (STED) for regulatory purposes.Support all the regulatory pre- and post-market activities related to technical aspects.Support the RD area to formalize:plan;phase gate documentation;verification documentation;validation.Implement and update internal procedures relevant to the above mentioned activitiesConduct or support internal audits. Support the preparation and review of relevant product technical marketing sheets, or ad hoc technical documentation requested to ensure continuity of product supply to the market.What are we looking for? Technical degree/ Master’s Degree in Engineering with an electronic background3/5 years in similar position in an implantable medical device company.Good knowledge of technical standards such as those listed below is a key requirement:10993 series11607 series11137 seriesF1980ST79FDA Guidance ‘Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling’Knowledge of relevant regulations and international standards (European MDD, MDR, FDA Guidances, ISO 13485, ISO 14971 etc.).Fluent English, both written and oralVery good knowledge and ability to use standard office applications What are you going to improve?Methodical and critical thinking.Excellent organizational and project management skills.Problem solving skills and “can do” attitudeAbility to work precisely according to procedures, rules and regulationsAdherence to timelines and result oriented attitudeOrderliness and attention to detail Analytical approach to resolve complex issuesAbility to work in team and autonomouslyAccountability for the assigned tasksTravel 10-15%What will you find?Friendly, warm, and innovative atmosphereHealthy, inspiring, and international and inclusive work environmenttraining and development opportunities Smart working model (two days per week)Competitive reward packagesSocial and company eventsWellbeing initiatives (welfare- yoga classes)Canteen Benefits (Pension Fund- Health Insurance)What do we offer?This is a full-time jobThe contract is permanentSalary package range: 40.000/45.000 euroDo you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to careers@orthofix.com