Design Assurance Engineer

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 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:

• 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:

• Biocompatibility
• Steam sterilization
• Device reprocessing
• Terminal sterilization
• Packaging validation

And consist of:

• Development of validation test plans, protocols, reports and summaries
• Organization and coordination of internal and external testing activities
• Maintenance of the existing validations according to international/regulatory requirement

Additional 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 products or modified products and cooperate with Regulatory Affairs Area 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 plan, 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 similar position in an implantable medical device company.

• ISO 10993 series
• ISO 11607 series
• ISO 11137 series
• ASTM F1980
• ANSI/AAMI ST79
• FDA 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 the difference? We look forward to your application. Please send it to careers@orthofix.com