Principal Software Design Assurance Engineer

ABOUT INSPIRE MEDICAL SYSTEMS

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.

Our focus on patient outcomes is at the core of everything we do, and our think I can attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

WHY JOIN OUR FAST-GROWING TEAM

At Inspire, we value people your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community.

We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!

ABOUT THIS POSITION

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 individual will also be responsible for assessing manufacturing changes ensuring both the design integrity and process control requirements are fulfilled.

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 Inspire 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.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

• 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 communicating & resolving 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 and / or lead 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.

Required Qualifications

• Associate’s degree in a software related field
• Bachelor’s degree in a technical or scientific field
• 1-2 years minimum experience of relevant medical device software quality or software design assurance role for finished medical devices
• Experience working with bug tracking tools such as JIRA
• Experience in software design reliability, process and product quality assurance functions.
• Strong project and time management skills
• Ability to work on multiple tasks concurrently with changing priorities
• Proficient with of MS Word, Excel and PowerPoint
• Strong project and time management skills
• Ability to work on multiple tasks concurrently with changing priorities
• Proficient with of MS Word, Excel and PowerPoint

Preferred Qualifications

• 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 ISO14971 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 CRF Part 820, 821, 822)
• Experience with Class III active implantable products.
• Experience working with HIPPA and GDPR.
• ASQ certifications; CSQE, CRE, CQM, CQE, etc.
• Experience with GHTF requirements for process validations, etc.

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