Senior Design Quality Engineer
San Diego, US
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organization. We have recently launched the innovative LumiraDx Platform and fast lab solutions, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
The Senior Design Quality Engineer provides design assurance (premarket quality) leadership and support to the LumiraDx molecular diagnostics and protein reagent businesses located in San Diego, CA and Solana Beach, CA. Responsible for quality activities of the Design and Development process of IVD assays through the development, verification and validation phase, manufacturing, release and post market phase, and implementation of changes and improvements to existing products. Leads quality aspects of design transfer. Reporting to the Director of Quality Assurance, the Senior Design Quality Engineer will work collaboratively with the San Diego design & development team as well as other internal and external groups.
Key Roles and Responsibilities
- Develops and leads a team to accomplish goals.
- Plan and lead design assurance (premarket quality) across various phases of medical device product development, including design and development planning, requirements definition, root cause analysis, test method development, design verification/validation, and design transfer.
- Represents quality for project teams throughout product lifecycle and product realization activities
- Organize, host and facilitate risk management related activities and design reviews with the project teams and ensure compliance of such activities to the applicable standards and regulations.
- Represent premarket quality on project teams to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development lifecycle.
- Responsible for all aspects of design and development quality assurance and compliance to 21 CFR 820, ISO 13485, ISO 14971, EU IVDR, and other applicable requirements.
- Responsible for ensuring both compliance and effectiveness of new products and manufacturing processes. Provides support in problem solving and root cause analysis. Proactively identifies and mitigates risk.
- Collaborate in the writing of design requirements and specifications, Verification and Validation plans and protocols, and traceability matrices.
- Works collaborative with Director of Quality Assurance to support all site business goals.
- Ensures design and development activities have a smooth hand-off to LumiraDx manufacturing sites.
We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem-solving and communication, along with the following experience:
- Bachelor’s degree in a scientific or technical discipline. Advanced degree and experience within in vitro diagnostics (IVD) is highly preferred.
- Significant experience in medical device design and development; experience with diagnostic devices highly preferred but not required.
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21 CFR Part 820, and Design Controls guidance documents
- Knowledge of molecular diagnostics and protein chemistry is highly preferred.
For further information and to apply for this role, please click APPLY