Software Design Assurance Engineer
7 days ago
We are a pioneering medical device company dedicated to revolutionizing the sleep industry with our innovative FDA-approved medical device. Our mission is to make a positive impact on the lives of individuals living with Obstructive Sleep Apnea (OSA). We strive to deliver exceptional patient outcomes and foster a culture of innovation, collaboration, and continuous learning.
Why Work with UsWe value diversity, inclusivity, and employee well-being. Our company culture is built on the principles of empathy, transparency, and open communication. We offer a comprehensive benefits package, flexible work arrangements, and opportunities for professional growth and development.
About This RoleThis position is responsible for ensuring the quality and reliability of our medical device software. The successful candidate will work closely with cross-functional teams to implement design control requirements, support product development projects, and ensure regulatory compliance. Key responsibilities include:
- Partnering with development teams to generate project deliverables and conducting audits to ensure quality and compliance.
- Ensuring design history content integrity, completeness, and regulatory compliance.
- Providing software design assurance services, including planning for software design validation, design transfer, and test system development and validation.
- Supporting risk management activities from product concept through commercialization.
- Providing quality engineering support for design changes, sustaining engineering projects, and supplier changes.
- Ensuring quality system procedural requirements and development life cycle phases are followed.
- Generating and/or approving design history file deliverables, engineering change orders, risk management documents, and device master record deliverables.
To be successful in this role, you will need:
- An Associate's or Bachelor's degree in a software-related field.
- 1-2 years of experience in a medical device software quality or software design assurance role.
- Experience working with bug tracking tools such as JIRA.
- Strong project and time management skills.
- Ability to work on multiple tasks concurrently with changing priorities.
- Proficiency in MS Word, Excel, and PowerPoint.
We are looking for candidates with:
- Comprehensive knowledge of medical software device design standards and global regulations.
- Demonstrated team leadership skills and ability to prioritize, execute, and report on projects.
- Experience with risk management standard ISO14971 and risk management tools such as dFMEA and pFMEA.
- Knowledge of ISO and FDA/Quality System Requirements.
- Experience working with Class III active implantable products.
- ASQ certifications; CSQE, CRE, CQM, CQE, etc.
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