Senior Software Design Assurance Engineer

ZipRecruiter; Minneapolis (MN); Hybrid; USD 107,000 - 162,000; Full time

Job summary

An innovative company is seeking a dedicated Software Quality Assurance Engineer to enhance medical device development. This role focuses on ensuring product reliability and compliance while collaborating with diverse teams to uphold quality standards. The ideal candidate will have extensive experience in medical device software quality assurance and a passion for improving patient outcomes. Join a forward-thinking organization that values your expertise and offers a hybrid work environment, competitive benefits, and opportunities for professional growth. If you are driven to make a difference through technology, this role is perfect for you.

Benefits

401k Matching

Tuition Reimbursement

Flexible Time Off

Health Insurance Options

Dental Insurance

Vision Insurance

Life Insurance

Employee Assistance Program

Equity Participation

Qualifications

• 8+ years in medical device software quality or design assurance.
• Deep knowledge of medical software device design standards.
• Experience with HIPAA and GDPR compliance.

Responsibilities

• Ensure quality objectives are met during product development.
• Collaborate with cross-functional teams for compliance.
• Support design changes and risk management activities.

Skills

Medical Device Software Quality Assurance

Project Management

Risk Management (ISO14971)

Regulatory Compliance (ISO 13485)

Multitasking Skills

Education

Bachelor’s Degree in Technical or Scientific Field

Tools

JIRA

MS Word

MS Excel

MS PowerPoint

Job description

Job Description

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. 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.

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!

ESSENTIAL JOB FUNCTIONS

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, support multiple product development projects with a primary focus on software projects, and ensure that quality objectives are met during the product development and design transfer lifecycle. Additionally, they will assess manufacturing changes to ensure design integrity and process control requirements are fulfilled.

This role involves performing tasks that assure high product reliability, regulatory compliance, and providing technical guidance to Inspire staff on quality and compliance matters throughout the product lifecycle. The individual will collaborate with Development, Operations, Manufacturing, Regulatory, Quality, and other global teams to ensure adherence to Inspire procedures and regional regulations.

OPPORTUNITIES IN THIS ROLE

• Partner with Development to generate project deliverables and conduct audits prior to product release.
• Maintain design history content integrity, completeness, and compliance; communicate and resolve gaps with cross-functional teams.
• Provide software design assurance services, including planning for validation, design transfer, test system development, and validation, along with root-cause analysis and resolution.
• Partner on validation of software test environments and tools, including methodology, protocols, and acceptance criteria.
• Support risk management activities from concept to commercialization.
• Ensure compliance with global medical device software and security standards, lead updates, and conduct compliance reviews.
• Support design changes, sustaining engineering, and supplier changes with quality engineering expertise.
• Work with cross-functional teams to identify controls and support product development from concept to market.
• Ensure adherence to quality system procedures and development lifecycle phases.
• Implement proper cybersecurity testing and controls, documenting all activities.
• Generate and approve DHF deliverables, ECOs, risk management documents, and DMRs.
• Provide leadership, coaching, and mentorship to engineering teams to uphold best practices in software quality engineering.
• Apply systematic problem-solving methodologies to identify, prioritize, and resolve quality issues.
• Support internal and external audits and other quality initiatives as needed.

QUALIFICATIONS

Required:

• Bachelor’s degree in a technical or scientific field
• Minimum 8 years of experience in medical device software quality or software design assurance for finished devices
• Deep knowledge of medical software device design standards and global regulations
• Proven leadership skills and project prioritization ability
• Knowledge of medical device data systems (MDDS)
• Experience with risk management standards like ISO14971 and tools such as dFMEA and pFMEA
• Familiarity with ISO and FDA/Quality System Requirements (e.g., ISO 13485, IEC 62304, 21 CFR Part 820, 821, 822)
• Experience with HIPAA and GDPR compliance
• Strong project management and multitasking skills
• Proficiency in MS Word, Excel, and PowerPoint
• Experience with Class III active implantable products

Preferred:

• Experience in software reliability, process, and product quality assurance
• Relevant ASQ certifications (CSQE, CRE, CQM, CQE)
• Experience with bug tracking tools like JIRA
• Knowledge of GHTF process validation requirements

SALARY

Expected between $107,700 - $161,500, offered based on experience and qualifications. This range may vary based on location, experience, education, and skills.

BENEFITS AND OTHER COMPENSATION

Inspire offers a competitive benefits package including health insurance options, HSA contributions, dental, vision, life insurance, 401k with match, flexible time off, tuition reimbursement, Employee Assistance Program, and equity participation through stock programs.

Inspire Medical Systems is an equal opportunity employer committed to diversity and inclusion. Applicants needing accommodations should contact Human Resources at 844-672-4357 or email [e-mail]. We participate in E-Verify.