Senior IVD Systems Engineer
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 organisation. We have recently launched the innovative LumiraDx Platform, 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
Job Title: Senior IVD Systems Engineer (Waltham, MA)
Job site: 221 Crescent Street, Suite 502, Waltham, MA 02453
Documents user requirement, develop system requirements, participate in product architecture and design, drive risk analysis, and usability engineering and support integration and testing activities for both in-market products as well as new product introduction.
- Be instrumental in architecting system level design for next generation of the products running on custom Linux OS by contributing to software and hardware design proposals, design reviews, rapid prototyping and by presenting the design to stake holders.
- Contribute in building and maintaining Yocto custom Linux environment (Using C, C++, Python and Linux skills) by providing incremental improvements to support continuous improvement.
- Provide technical support in diagnosing & investigating application failure in production environment and perform defect analysis, FMEA and risk assessment for the solutions and remediations.
- Knowledge transfer to new hires and junior engineers for their smooth onboarding and their ongoing tasks by providing technical guidance for existing and new software features of the IVD product as well as adopted software development process.
- Contribute in designing, developing, maintaining and troubleshooting the software upgrade methodologies for the core system, assay processing controllers and communication module(s) using expertise in bootloader design, over the air update & memory management;
- Provide knowledge transfer and guidance to junior engineers for development and maintenance of medical device software on various IVD products based on ARM microcontroller (STM32 or nRF52).
- Implement low level software using skills in C, C++ and expertise in device driver development, object framework & various communication protocols.
- Develop high quality engineering tools using scripting languages to help automate the V&V efforts for existing and next generation of IVD products both on-target and off-target.
- Participate in writing and submitting technical documentation such as SOUP analysis, remediation review file, impact analysis (IA), planned deviation (PD), quality event (QE) and risk assessments to meet the regulatory requirements for medical device industry standards.
- Collaborate with functional leaders in software, hardware, assay development, research, quality assurance, commercial and manufacturing, as well as have interactions with customers, clinicians, third-party vendors, manufacturers, and others.
Master’s degree (or foreign equivalent) in Computer Science, Electrical Engineering, Computer Engineering or a related field, plus 3 years’ experience with software development.
Experience may be gained concurrently and must also include:
- 3 years’ experience developing clean and good quality software using C, C++, C# and Python programming languages for both Windows and Linux based environments in compliance with coding standards accepted for medical devices.
- 3 years’ hands-on experience designing and developing embedded software on “Bare silicon” and variety of RTOS (such as Threadx) using multithreading, inter-task messaging, troubleshooting low level drivers, interrupts, watchdog timer, thread scheduling, memory management and various board support packages.
- 3 years’ experience developing and troubleshooting communications protocol such as SPI, UART, I2C, CAN, USB as well as wireless protocols such as BLE using debugging tools and protocol analyzers (including Saleae logic, Frontline).
- 3 years’ experience working with Quality/Regulatory Teams to create and maintain approved quality system that meets the requirements of IEC-62304 for Medical device software life cycle and UL2900 for software cybersecurity and ISO-13485 for medical devices quality management system.
- 2 years’ experience documenting design activities such as: Generating system/subsystem design (ERD) documents, workflows (DFD), sequence/ladder diagrams, UML diagrams and attending design control reviews.
- 2 years’ hands-on experience working with source control such as GIT, code review tools such as Gerrit, Jenkins based continuous integration (CI) environment, and writing unit tests using Cmake and/or Ceedling.
- 1 year experience developing applications for software module/stacks interacting with system bus (using RPC such as DBus) running on a custom embedded Linux environment running on a system on module (such as i.MX8).
- 1 year experience with over the air firmware upgrades, device bootloader and power on self-tests.
- 1 year experience working with tools such as JIRA, JAMA for product development life cycle.
- 1 year experience working in an agile release train and SAFe principles.
To apply please refer to Job Code: GS54495
For further information and to apply for this role, please click APPLY