Software Quality Assurance Engineer

This range is provided by Insight Global. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Insight Global is seeking a Sr Software Design Assurance Engineer for one of our local medical device clients. This position is responsible for product software quality assurance support of new product development projects and design changes. This individual will ensure design control requirements are implemented and followed, will support multiple product development projects with a primary focus on software projects. This individual will ensure that the quality objectives are met during the product development and design transfer life cycle.

This position is responsible for performing tasks that will assure a high level of product reliability along with regulatory compliance and provide technical direction to staff on matters of quality and compliance throughout the product’s lifecycle. This position will 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.
• Support risk management activities from product concept through commercialization.
• 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 when applicable 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.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel to ensure best‑in‑class Software Design Quality Engineering practices.
• Applies 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.

• Associate’s degree in a technical or scientific field.
• 5 years minimum experience with medical device software quality or software design assurance role for finished medical devices.
• Comprehensive knowledge on 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 on medical device data systems (MDDS).
• Experience with risk management standard ISO 14971 as well as risk management tools such as dFMEA and pFMEA.
• Knowledge on ISO and FDA/Quality System Requirements. (e.g., ISO 13485; ISO 14969; IEC 62304, FDA 21 CFR Part 820, 821, 822)
• Experience working with HIPAA and GDPR.
• Strong project and time management skills.
• Ability to work on multiple tasks concurrently with changing priorities.
• Proficient with MS Word, Excel and PowerPoint.
• Experience with Class III active implantable products.

• Associate

• Full-time

• Engineering and Information Technology
• Medical Equipment Manufacturing

• Medical insurance
• Vision insurance
• 401(k)