Design Assurance Engineer

The company’s proprietary technology senses and measures neural responses to stimulation and automatically adjusts therapy based on real‑time neurophysiological feedback. Saluda Medical’s first product, the Evoke® System, is designed to deliver known, consistent, and personalized spinal cord stimulation therapy by objectively measuring neural responses and maintaining therapy within a prescribed therapeutic window.

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.

About saludamedical

• Saluda Medical is a commercial‑stage medical device company focused on developing treatments for chronic neurological conditions using its novel closed‑loop neuromodulation platform.
• Saluda Medical is headquartered in Minneapolis, Minnesota.
• At Saluda, we challenge boundaries.
• We innovate and think beyond the conventional.
• Our focus is to revolutionize the standard of care in neuromodulation to positively impact patient’s lives.
• Integrity – Do the right thing Pioneering – Lead Boldly, Change Lives, Disrupt the Status-Quo Performance – Win together – Deliver with Excellence.

Responsibilities

• Specifically, this role will provide quality engineering support to the development of product requirements, product verification and validation, risk management, and design change control.
• 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.

Requirements

• 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.
• 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.