Senior Software Design Assurance Engineer

Inspire Medical Systems; Saint Paul (MN); Hybrid; USD 107,000 - 162,000; Full time

Job summary

Join a forward-thinking company dedicated to revolutionizing the sleep industry with innovative medical devices. As a Senior Software Design Assurance Engineer, you will play a pivotal role in ensuring product quality and compliance in a collaborative environment. With a focus on patient outcomes and integrity, you will support multiple product development projects and lead efforts in software quality assurance. This position offers a hybrid work schedule, excellent benefits, and opportunities for professional growth. If you are passionate about making a difference through technology, this role is perfect for you.

Benefits

Health Insurance

401k Matching

Tuition Reimbursement

Flexible Time Off

HSA Contributions

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Qualifications

• 8+ years experience in medical device software quality or design assurance.
• Knowledge of medical software design standards and global regulations.

Responsibilities

• Support product software quality assurance for new development projects.
• Ensure design control requirements are followed and product reliability.

Skills

Medical Device Software Quality Assurance

Design Assurance

Risk Management Standards (ISO14971)

Project Management

Knowledge of ISO, FDA Regulations

Leadership Skills

Proficiency with MS Office

Education

Bachelor’s Degree in Technical or Scientific Field

Tools

JIRA

Job description

Senior Software Design Assurance Engineer

Join to apply for the Senior Software Design Assurance Engineer role at Inspire Medical Systems.

Job Details

2 weeks ago Be among the first 25 applicants.

Inspire Medical Systems provides a pay range:
This range is provided by Inspire Medical Systems. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Salary Range

$107,700.00/yr - $161,500.00/yr

About Inspire Medical Systems

Inspire is a medical device designed to improve the lives of those with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved device, which reduces OSA severity for patients intolerant to CPAP. We are committed to patient outcomes, integrity, and respect, fostering a positive, innovative environment.

Why Join Our Team

We value diversity, encourage learning, and offer hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off, and tuition reimbursement. Join us if you are passionate about making a difference with technology!

Key Responsibilities

• Support product software quality assurance for new development projects and design changes.
• Ensure design control requirements are followed.
• Support multiple product development projects, focusing on software.
• Assess manufacturing changes for design integrity and process control.
• Ensure product reliability, regulatory compliance, and provide technical guidance.
• Collaborate with Development, Operations, Manufacturing, Regulatory, and Quality teams globally.

Qualifications

Required:

• Bachelor’s degree in a technical or scientific field.
• Minimum 8 years experience in medical device software quality or design assurance.
• Knowledge of medical software design standards and global regulations.
• Leadership skills and project prioritization ability.
• Experience with risk management standards (ISO14971) and tools (dFMEA, pFMEA).
• Knowledge of ISO, FDA, and related quality system requirements.
• Experience with HIPAA and GDPR.
• Strong project and time management skills.
• Proficiency with MS Office.
• Experience with Class III active implantable devices.

Preferred:

• Experience in software reliability, process, and quality assurance.
• Certifications like CSQE, CRE, CQM, CQE.
• Experience with JIRA or similar tools.
• Knowledge of GHTF process validations.

Additional Details

The salary is expected between $107,700 and $161,500, based on experience and qualifications. Benefits include health insurance, HSA contributions, dental, vision, life, disability, 401k with match, tuition reimbursement, and more. Inspire is an equal opportunity employer and participates in E-Verify.