Magic Leap’s mission is to harmonize people and technology to create a better, more unified world. Magic Leap is a team of creatives and technologists building a personal, spatial computing platform that seamlessly blends the digital and physical worlds. Magic Leap’s healthcare team is changing the world of healthcare and is looking to expand its team.
The Senior Quality Engineer, Healthcare NPD (New Product Development) will oversee all quality aspects of new product development and product maintenance (post-market) for medical devices. This role will be embedded in the design process with particular focus on software and will ensure that quality is designed into the product.
- Participate and contribute to all medical device 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) and cybersecurity.
- Serve as team’s subject matter expert for quality guidance on recognized software lifecycle standards such as IEC 62304 and FDA’s guidances on software validation, mobile medical applications, digital health, and OTS. Candidate will also provide quality guidance on international requirements for software such as EU’s MDR and MEDDEV 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 includes adequate commenting 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 in 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.
- Support Quality Systems team during Management reviews.
- Develop and nurture cooperative relationships with all design teams and between varied design functions.
- Motivate and inspire a quality culture across Magic Leap.
- 8+ years experience in Quality - New Product Development or R&D Organization serving as a project team’s quality engineer with particular focus on supporting development and commercialization of software-based products
- Familiar with software languages such as C, C++, and C# as well as gaming engines including Unity/Unreal
- Experience in application of requirements for medical device development including but not limited to software-as-medical device, design controls (CFR 820, ISO 13485) and risk management (ISO 14971)
- Solid knowledge of engineering fundamentals and proven ability to apply this knowledge to new product development and manufacturing
- Strong communication skills both verbal and written
- Strong understanding of software systems and cybersecurity
- ASQ certification as a Software Quality Engineer is preferred.
Education and/or Experience: Bachelor's degree from four-year University in Electrical, Mechanical, Computer Engineering or equivalent based upon experience.