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Senior Quality Assurance Engineer, Medical Device
3 years ago
Job Description
Magic Leap is seeking an experienced and dynamic Senior Quality Assurance Engineer that will oversee all quality aspects of new product development and product maintenance (post-market) for products intended for medical use. This role will be embedded in the design process with particular focus on software and will ensure that quality is designed into the product.
Responsibilities
- Participate and contribute to all health development projects with particular focus on software.
- Provide leadership, guidance and expertise on Magic Leap’s development process, procedures and practices.
- Provide expertise and ensure project compliance with all medical device industry standards and regulations including but not limited to:
- Software development lifecycle (IEC 62304)
- Design controls (CFR 820 and ISO 13485)
- Risk management (ISO 14971)
- Usability/human factors (IEC 62366)
- Electronic records (CFR11)
- Cybersecurity (ISO/IEC 27001)
- Serve as team’s subject matter expert for quality guidance on recognized software lifecycle standards such as IEC 62304 and FDA’s guidance on software validation, mobile medical applications, digital health, and OTS. The Candidate will also provide quality guidance on international requirements for software such as the EU's MDR guidelines for CE Mark of SaMD.
- Key contributor of design deliverables related to software such as traceability matrices, module/integration/system level testing, software risk analysis, SRS, SDS.
- Ensure code design and description are properly documented and linked for proper traceability to requirements, hazards, and testing.
- Oversee, review and approve/reject all documentation outputs of the design control process.
- Seek opportunities to continually improve existing Design and Development processes.
- Assist regulatory filings and inspections.
- Conduct training on Software Quality Systems / Software As A Medical Device.
- Support Regulatory Team to ensure all applicable medical device standards are incorporated in the product design.
- Investigate and report on field quality issues, failures, and complaints and work to resolution (i.e., CAPA).
- Support internal and external audits of SaMD products and processes.
- Provide quality support for audits of Software Suppliers, Software Consultants as well as Non-Software Suppliers.
- Develop and nurture cooperative relationships with all design teams and between varied design functions.
- Motivate and inspire a quality culture across Magic Leap.
Qualifications
- 5+ years experience working in medical device product development leading projects from inception to release.
- Track record of creative problem solving, and successfully delivering complex technical projects within defined constraints.
- Experience with HW, SW, and System product development, including consumer electronics, sensors, and complex systems.
- Experience with enterprise cloud solutions, and/or with AR/VR is a great plus.
- Well versed in FDA/EU requirements for medical device development.
- Skilled at establishing and maintaining good working relationships with peers, management, and team members throughout the organization.
- Familiar with Agile, Waterfall, and Scrum methodologies.
- Ability to quickly understand complex, interdependent technical requirements.
- Excellent organizational, communication and interpersonal skills.
- Excellent analytical skills, attention to detail, and ability to follow issues through resolution.
Education
Education and/or Experience: Bachelor's degree from four-year University in Electrical, Mechanical, Computer Engineering or equivalent based upon experience.
Additional Information
- All your information will be kept confidential according to Equal Employment Opportunities guidelines.
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