Design Assurance Engineer
Saluda Medical
full-time
Posted on:
Location Type: Hybrid
Location: Macquarie Park • 🇦🇺 Australia
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Work on a cross-functional team to identify and implement effective design controls and support product development from concept through commercialization.
- Understanding of Design Assurance requirements to support product design and design changes through cross-functional team collaboration, to ensure activities comply to all internal and regulatory requirements.
- Mentor cross functional teams through product development process; specifically, with respect to design control and risk management deliverables.
- Completes 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 partnership.
- Support changes to DHF documentation.
- Review and approve design verification test plans, protocols and reports.
- Develop test method validation requirements.
- Utilize statistical analysis techniques to determine required level of product reliability and evaluate process capabilities.
- Provide Quality input to sustaining commercial product, process improvements and change control.
- Support cross functional team to develop protocols to ensure that design/process changes are adequately evaluated/tested with respect to standard requirements.
- Plan, organize and prioritize own daily work routine to meet established schedule.
Requirements
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Design AssuranceFMEARisk ManagementStatistical analysisTest method validationDesign verificationQuality inputProcess improvementsChange controlDHF documentation
Soft skills
Cross-functional collaborationMentoringCommunicationOrganizational skillsAnalytical skillsIndependenceFlexibilityTeam-orientedPresentation skillsPrioritization
Certifications
Bachelor’s degreeISO 13485ISO 1497121 CFR 820