Position 1: Principal Software Engineer (Embedded Software Engineer)
Salary: $125K per annum + Benefits.
Location: Lake Forest, CA
The Principal Software Engineer, Medical Device Systems is responsible for maintaining, enhancing, and supporting software for Client's on-market ophthalmic medical devices and imaging platforms. This role requires a strong background in C++, C#, hardware/software interfaces, and medical device or instrumentation systems, with highly desired experience in MATLAB, camera integration, imaging technologies, firmware interaction, FPGA-based systems, LabVIEW, and RTOS environments. The engineer will investigate software anomalies, assess the impact of hardware and component changes, support cybersecurity and compliance initiatives, and implement robust software solutions that ensure product performance, reliability, and patient safety throughout the product lifecycle.
The role serves as a key liaison between engineering, customer-facing teams, product security, verification and validation, and global software development organizations. It ensures that software changes are properly assessed, documented, tested, and released in accordance with quality system requirements and medical device regulations.
The Principal Software Engineer collaborates closely with onshore and offshore development and V&V teams throughout the software development lifecycle, providing technical inputs for testing, validating software modifications, supporting troubleshooting activities, and maintaining software configuration management. The role enables successful delivery of software updates while ensuring adherence to company policies, regulatory requirements, and product quality standards.
In this role, a typical day will include:
- Primary function is to code and/or software updates for on-market medical device systems.
- Collaborate closely with the software development teams, Technical Support, Field Service, Manufacturing, Clinical and other operation organizations to support necessary software changes initiated by reported anomalies, changes in use cases, material or hardware changes that impact software, cybersecurity, regulatory updates, and other.
- Troubleshoot, and define solutions to meet expectations, and incorporate changes according to defined processes and procedures, in line with industry standards and regulations.
- Maintain configuration management and change control according to the associated product Configuration Management Plan and Change Control procedures.
- Document and execute change-related unit and integration tests. Provide inputs for scope, impact, and effective test methodologies for testing.
- Assure compliance to software release procedures for post-Market changes to on-market products.
- Travel required, est. 10-20%
Key Requirements/Minimum Qualifications:
- Bachelor s Degree or Equivalent years of directly related experience (or high school +13 yrs.
- Assoc.+9 yrs.; M.S.+2 yrs.; PhD+0 yrs.)
- The ability to fluently read, write, understand, and communicate in English
- 5 Years of Relevant Experience.
Preferred Qualifications:
- Technical Development Methodology for Medical Devices (21 CFR 820.30, ISO 13485)
- Systems Engineering or Risk Management for Medical Device (ISO 14971)
- Medical Device Software Software Life Cycle Processes (IEC 62304)
- Regulations and Guidelines associated with software development for medical device
- Microsoft Office suite (i.e., Word, Excel, Visio)
- Must have C++, C# development experience.
- Must have a background with hardware/software interfaces within RTOS and Windows environments.
- Highly desired skills: MATLAB, LabView, FPGA, Firmware, and experience with camera interactions and interfaces.
- Familiar with object-oriented software design and large software architecture.
- Ability to work cross-functionally with a variety of stakeholders.
- Ability to work independently, proactively identify issues, recommend, and implement solutions, and deliver quality
- results on schedule while managing multiple tasks and internal customers.
- Solid understanding of Window operating environments (Win11, Win10, etc.)
- Experience with one or more software configuration management systems and related tools, such as: AWS DevOps,
- Jira, Git, ADO, GitHub, TFS
- Knowledge of networking and cybersecurity concepts are a plus.
- Experience with Microsoft Visual Studios or other integrated development environment (IDE) tools
- Prior experience creating and executing software testing at unit, sub-system, integration, and system levels.
- Familiar with FDA/ISO regulations for software development and/or EUMDR, prefer including IEC 62304
- Understanding of Software Development Lifecycle Management (SDLC) (Agile/Scrum, iterative)
- Good interpersonal & Communication skills to build positive departmental and inter-departmental relationships in a
virtual, remote, and asynchronous environment.
- Medical device experience is preferred.
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