We are looking for a Design Assurance Engineer to join our Quality & Regulatory Department, based in Bussolengo (Verona).
Position Summary:
The role is the liaison between Research & Development (R&D), Process Engineering, Quality Operations, and Regulatory Affairs during the Design & Development of new products.
The primary goal is to achieve and maintain product-specific validations for attributes such as biocompatibility, sterility, reprocessing, and packaging.
Additionally, the role is expected to:
Guarantee that Design & Development activities are conducted in compliance with internal procedures and in conformity with standards, directives, and laws applicable to the Organization;Work closely with R&D 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.
Main Responsibilities: These are related to product aspects such as:
BiocompatibilityDevice reprocessingAnd consist of:
Development of validation test plans, protocols, reports, and summariesOrganization and coordination of internal and external testing activitiesMaintenance of the existing validations according to international/regulatory requirementsAdditional Responsibilities: 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 R&D, Marketing, Medical Science, and Clinical Affairs, the design validation of new products.Prepare and maintain, as required, Technical File documentation for new or modified products and cooperate with Regulatory Affairs to prepare regulatory submissions.Prepare and maintain Summary Technical Documentation (STED) for regulatory purposes.Support all the regulatory pre- and post-market activities related to technical aspects.Support the R&D area to formalize development plans, development phase gate documentation, design verification documentation, and design validation.Implement and update internal procedures relevant to the above-mentioned activities.Conduct 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.Education:
Technical degree/Master's Degree in Engineering with an electronic background.
Business Skills:
3 years in a similar position in an implantable medical device company.
Good knowledge of technical standards such as:
ISO 10993 seriesISO 11607 seriesISO 11137 seriesASTM F1980ANSI/AAMI ST79FDA 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.
).
Languages: Fluent English, both written and oral.
Computer Skills: Very good knowledge and ability to use standard office applications.
Do you want to join us?
Are you ready to make a difference?
We look forward to your application.
Please send it to ******
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