Principal Design Assurance Engineer

Principal Design Assurance Engineer – Inspire Medical Systems

2 days ago – Be among the first 25 applicants.

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA‑approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation.

We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.

• Support product software quality assurance of new product development projects and design changes.
• Ensure design control requirements are implemented and followed; support multiple product development projects with a primary focus on software projects.
• Ensure the quality objectives are met during the product development and design transfer life cycle.
• Assess manufacturing changes ensuring both the design integrity and process control requirements are fulfilled.
• Perform tasks that assure a high level of product reliability along with regulatory compliance and provide technical direction on quality and compliance throughout the product’s lifecycle.
• Work with Development, Operations, Manufacturing, Regulatory, Quality and other functional areas globally to ensure work is completed in accordance with Inspire procedures and geographic regulations.

• Partner with Development to generate project deliverables and conduct audits of the deliverables prior to product release.
• Ensure design history content integrity, completeness, and regulatory / standards compliance; collaboratively communicate & resolve gaps with cross‑functional team members.
• Provide product software design assurance services, including planning for software design validation, design transfer, test system development and validation, including active cross‑functional root‑cause analysis investigation and resolution.
• Partner with Development on the validation of software test environments and software tools, including test methodology, test protocol and acceptance criteria development.
• Lead risk management activities from product concept through commercialization.
• Provide product expertise and guidance on global medical device software and security standards or other specific industry standards to ensure compliance with those standards. Lead and document standard updates and compliance reviews at the prescribed frequency.
• Provide quality engineering support for design changes, sustaining engineering projects and supplier changes.
• Work within a cross‑functional team to identify and implement effective controls and support product development from concept through commercialization.
• Ensure quality system procedural requirements and development life cycle phases are followed.
• Ensure proper cyber security testing and controls are utilized and documented.
• Generate and/or approve the following: DHF deliverables, Engineering Change Orders (ECOs), Risk Management documents and Device Master Record (DMR) deliverables.
• Provide project direction, coaching, and mentoring for engineering and technical team personnel to ensure best‑in‑class software design quality engineering practices.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Support both internal and external audit activities.
• Support other quality projects and initiatives as assigned.

• Bachelor’s degree in a technical or scientific field.
• 12 years minimum experience in a medical device software quality or software design assurance role for finished medical devices.
• Comprehensive knowledge of medical software device design standards along with global regulations for medical device software design.
• Demonstrated team leadership skills and ability to prioritize, execute and report on projects.
• Knowledge of medical device data systems…