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Senior Software Design Quality Engineer
2 months 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 meaningful difference in the lives of individuals living with Obstructive Sleep Apnea (OSA). We prioritize patient outcomes and foster a culture of collaboration, learning, and growth.
Why Work with UsWe value diversity, equity, and inclusion, and we strive to create a workplace where everyone feels valued and empowered. Our benefits package includes hybrid work schedules, comprehensive health insurance, 401(k) matching, employee stock purchase plan, flexible time off, and tuition reimbursement. We also offer opportunities for professional development and community engagement.
About This RoleThis position is responsible for ensuring the quality and reliability of our medical device software. The successful candidate will work closely with our development team to implement design control requirements, support multiple product development projects, and ensure regulatory compliance. This role requires strong technical expertise, excellent communication skills, and the ability to work collaboratively with cross-functional teams.
Key Responsibilities- Partner with development to generate project deliverables and conduct audits of deliverables prior to product release.
- Ensure design history content integrity, completeness, and regulatory compliance.
- Provide product software design assurance services, including planning for software design validation, design transfer, test system development, and validation.
- Support and/or lead risk management activities from product concept through commercialization.
- Provide quality engineering support for design changes, sustaining engineering projects, and supplier changes.
- Work with cross-functional teams 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 cybersecurity testing and controls are utilized and documented.
- Generate and/or approve design history file deliverables, engineering change orders, risk management documents, and device master record deliverables.
- Provide project direction, coaching, and mentoring for engineering and technical team personnel.
- Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
- Support internal and external audit activities.
- Associate's degree in a software-related field or Bachelor's degree in a technical or scientific field.
- 1-2 years of experience in a 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 MS Word, Excel, and PowerPoint.
- Comprehensive knowledge of medical software device design standards and global regulations for medical device software design.
- Demonstrated team leadership skills and ability to prioritize, execute, and report on projects.
- Knowledge of medical device data systems (MDDS).
- Experience with risk management standard ISO14971 and risk management tools such as dFMEA and pFMEA.
- Knowledge of ISO and FDA/Quality System Requirements.
- Experience with Class III active implantable products.
- Experience working with HIPAA and GDPR.
- ASQ certifications; CSQE, CRE, CQM, CQE, etc.
- Experience with GHTF requirements for process validations, etc.