Design Assurance Engineer

vor 10 Stunden

Council of the City of Sydney, Österreich Saluda Medical Vollzeit

Design Assurance Engineer – Saluda Medical The Design Assurance Engineer is a quality engineering role that supports new product development, sustaining engineering and post‑market activities. Reporting to the Director of Operations Quality and Quality Systems, this role provides quality engineering support to cross‑functional teams to ensure design controls and subsequent production and process controls are adequate. Specifically, it supports development of product technical documentation including requirements, product verification and validation, risk management, and design change control. Responsibilities Work on a cross‑functional team to identify and implement effective design controls and support product development from concept through commercialization. Apply Design Assurance requirements to support product design and design changes through cross‑functional collaboration, ensuring activities comply with all internal and regulatory requirements. Mentor cross‑functional teams through the product development process with respect to design control and risk management deliverables. Complete risk analysis studies of design and processes using FMEA and other risk management tools. Maintain up‑to‑date knowledge of developments in regulatory compliance requirements for product design, development, transfer, and commercialization activities. Represent quality by supporting quality disciplines, decisions, and practices. Liaise with departments, both internally and externally, to build strong collaborative partnerships. Support changes to Design History File documentation. Review and approve design verification test plans, protocols and reports. Develop test method validation requirements. Utilize statistical analysis techniques to determine required levels of product reliability and evaluate process capabilities. Provide quality input to sustaining commercial product, process improvements and change control. Support cross‑functional teams to develop protocols to ensure that design/process changes are adequately evaluated and tested with respect to standard requirements. Plan, organize and prioritize own daily work routine to meet established schedules. Required qualifications Bachelor’s degree or higher in a technical field (Biomedical, Mechanical, Electrical, Software Engineering or other technical field). Comfortable working independently and as part of a cross‑functional team. Flexible and positive attitude, team‑oriented. Good communication skills (verbal and written), comfortable speaking and presenting to others. Ability to manage multiple priorities and work with ambiguity. Must be able to work independently under limited supervision. Strong analytical skills. Design Assurance work experience in the medical device industry. Working knowledge of ISO 13485, ISO 14971, 21 CFR 820. Preferred qualifications Design assurance experience in medical device firmware. Design assurance experience in medical device software. Medical device cybersecurity experience. Seniority level: Entry level Employment type: Full‑time Job function: Quality Assurance Industries: Medical Equipment Manufacturing Location: Macquarie Park, New South Wales, Australia #J-18808-Ljbffr

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