Design Assurance Engineer III

Effective understanding of requirements and procedures that govern medical device Design Control. Understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements. Provide design quality support in the resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes. Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, Operations and Post Market Teams (CIS, CMC and Trending) in a project team environment to provide technical and quality systems input. Development and execution of protocols and reports as part of Design Verification and Stability activities through the life cycle of the product. Draws conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities. Ownership of design change projects including scoping, assessment and implementation. Drive updates to documents within the Risk Management File, such as the Hazard Analysis, Task Analysis and Design FMEA. Work with cross functional, global teams to support execution of ICH stability studies for development, commercialisation and post-approval commitments of drug-device combination products. Development and execution of stability plan, protocols and reports for drug-device combination products as part of Design Verification activities through the life cycle of the product. Level 8 Honours Bachelor Degree (240 credits) qualification in a STEM discipline Minimum 5-years Design Assurance Engineering experience Experience in areas such as Post Market Surveillance, complaints, design control, risk management, design and process change, and standards compliance (to regulatory requirements) is key Strong technical capabilities, communication skills, teamwork abilities and initiative Proven ability to work well both as part of a team and individually.