Bachelor's degree in Biomedical, Mechanical, Electrical Engineering, or related technical field
Strong analytical skills
Good verbal and written communication skills
Ability to manage multiple priorities and work with ambiguity
Experience with FDA regulations or ISO standards (preferred)
Comfortable working independently and in cross-functional teams
Flexible and positive team-oriented attitude
Responsibilities
Collaborate with cross-functional teams to implement effective design controls
Support product design and changes to ensure compliance with internal and regulatory requirements
Mentor teams on design control and risk management deliverables
Conduct risk analysis studies using FMEA and other tools
Stay updated on regulatory compliance developments for product activities
Represent Quality in decision-making and practices
Liaise with internal and external departments to foster collaboration
Review and approve design verification test plans and reports
Benefits
Opportunity to work on innovative product development
Collaborative work environment with cross-functional teams
Mentorship opportunities within the organization
Exposure to regulatory compliance processes
Focus on integrity and performance in company culture
Full Job Description
The Design Assurance Engineer is a quality engineering role that supports new product development, sustaining engineering and post-market activities. This role will provide quality engineering support to cross-functional teams to ensure the application and compliance to design controls and subsequent production and process controls are adequate. Specifically, this role will provide quality engineering support to the development of product requirements, product verification and validation, risk management, and design change control.
What You'll Do:
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.
What You'll Bring:
Bachelor's degree or higher in a technical field (Biomedical, Mechanical, Electrical 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
Training experience to FDA regulations or ISO standards (preferred)
Our Core Values:
People - Our first responsibility is to the patients we serve.
Integrity - Do the right thing
Pioneering - Lead Boldly, Change Lives, Disrupt the Status-Quo
Performance - Win together - Deliver with Excellence.
About Saluda Medical
Saluda Medical is a medical device company that develops and commercializes neuromodulation technologies for the treatment of chronic pain. The company's Evoke closed-loop spinal cord stimulation system is designed to provide personalized, long-lasting pain relief to patients suffering from chronic pain. Saluda Medical was founded in 2013 and is headquartered in North Ryde, New South Wales, Australia.
