Senior Engineer, Design Assurance

We are looking for a Senior Engineer, Design Assurance to ensure compliance with international standards and regulatory requirements for cochlear implant technology. Lead design assurance for multiple projects, collaborate within multidisciplinary teams, and apply expertise in medical device regulations. Ideal for experienced professionals in product development and design assurance.

Skills

• design assurance
• medical device regulations
• iso 13485
• iso 14971
• iec 60601
• mdsap
• mdr
• 21 cfr 807
• 21 cfr 803
• 21 cfr 806
• 21 cfr 820
• eu mdr
• design for manufacturability
• design for six sigma
• quality management
• lean principles
• simulation
• testing strategy
• feasibility studies
• development of value and value graphs
• usability engineering
• capa
• regulatory submissions
• training delivery
• mentoring
• stakeholder management
• analytical skills
• technical skills
• solidworks cad
• minitab