Design Assurance Engineer Medical Devices

As Design Assurance Engineer you are responsible for creation of an overall quality plan, review of design verification and validation specifications, test specifications and reports for medical devices (devices and consumables), review of Design Control documents according to GDP, MDR 2017/CFR820 and leading/contributing to risk management, FMEA and other quality (assurance) related tasks within product development. Primary Responsibilities Within the framework of design control:

• Support on creation of overall superior quality plan including document plan and overall VnV plan
• Review of design verification and validation test specification for medical devices (equipment and consumables)
• Review of design control documents according to GLP, GDP, CFR820
• Member of the product and design FMEA team

As a member of the risk management team according to ISO 14971:

• Contribute to the content of the risk management throughout the product development
• Review of the systematics and completeness of the risk analysis
• Evaluation of risk-reducing measures regarding impact on severity of damage and probability of occurrence
• Creation and review of the evidence for implementation and effectiveness of the measures

In cooperation with Quality Assurance and Production:

• Involvement in the preparation of test specifications and test requirements for the series testing of medical devices

Other tasks:

• Active participation in measures for synchronization and improvement of processes
• Failure analysis for field returns and during development
• Strict compliance with quality, occupational safety and environmental regulations and implementation of instructions by quality/environmental officers and the specialist for occupational safety

• Completed technical and/or physical studies
• At least 2 years of professional experience
• Experience with product quality in a highly regulated industry (medical device, automotive, aviation etc.)
• Experience in theory and application of quality methods and techniques
• English language skills (B2)* required
• Quality-conscious, trustworthy and reliable
• Team player
• Good communication skills
• Structured and systematic way of working

Travel Requirements

• Willingness to travel to all locations and business contacts (10%)

Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific. Looking for a great place to work? You have found it with a culture that embraces teamwork, collaboration and empowerment. Come explore Novanta.