Design Assurance Engineer

Saluda is a global healthcare company that is redefining Spinal Cord Stimulation (SCS) therapy at the intersection of advanced AI, real-time diagnostics, and ground-breaking clinical evidence.  Every day at Saluda, we are focused on the dignity of responsibility to elevate human health and optimize clinician operations by unlocking the power of data and science to reach patients in need.

At Saluda, we challenge boundaries. We innovate and think beyond the conventional. We disrupt. With the passion and energy of an accomplished team of seasoned experts, our focus is to revolutionize the standard of care in the neuromodulation space by transforming the lives of patients suffering from debilitating pain. 

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.

Responsibilities:

• 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.

Qualifications:

• Bachelor’s degree or higher in a technical field (Biomedical, Mechanical, Electrical Engineering or another 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
• Training experience to FDA regulations or ISO standards preferred

Saluda Medical embraces diversity and equal opportunity. We are committed to building a team representative of a variety of backgrounds, perspectives and skills. We believe people are the source of our inspiration and innovation.

Saluda Medical does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Saluda Medical’s approved agency list. Unsolicited resumes or candidate information submitted to Saluda Medical by search/recruiting agencies not already on Saluda Medical’s approved agency list shall become the property of Saluda Medical.