Established Search · 1 day ago
Lead Software Engineer
California, United States
Full-time
Hybrid
Lead/Staff
15+ years expEstablished Search is supporting a commercial-stage medical technology company operating in the women’s health space, focused on delivering a novel, FDA-approved device. The Lead Software Engineer will own embedded software development across the full product lifecycle, lead software planning activities, and ensure compliance with regulatory standards.
Staffing & Recruiting
Hiring Manager
Chloé McCormack
Responsibilities
Own embedded software development across the full product lifecycle, from early design through manufacturing and field support
Lead software planning activities, including development plans, verification strategies, and release management
Design, implement and maintain embedded control software for an electromechanical medical device
Drive cost-reduction and design-for-manufacture initiatives through software and component optimisation
Execute bench testing and performance characterisation at component, subsystem, and system levels
Investigate field issues, analyse returned devices, and perform root cause analysis using real-world data
Improve system robustness through enhanced fault detection and handling
Coordinate and support software verification & validation activities
Author and maintain software requirements, architecture, and design documentation
Develop and maintain internal tools and third-party software integrations
Support manufacturing by maintaining and improving production test software
Contribute to regulatory submissions, audits, and quality system activities
Manage external software consultants when required
Participate in design reviews, risk management, and cross-functional technical discussions
Balance multiple priorities in a fast-moving, regulated product environment
Contribute to intellectual property development and technical strategy
Qualification
Required
BS or MS in Engineering, Computer Science, or a related technical discipline
15+ years' experience developing software in medical devices or similarly regulated industries
Strong proficiency in C for embedded systems, with a focus on best practices and reliability
Hands-on experience with microcontroller-based systems (e.g. TI MSP430 or similar architectures)
Background developing control software for electromechanical systems
Strong technical documentation and writing skills
Solid working knowledge of IEC 62304, ISO 14971, and relevant FDA guidance
Practical experience with software V&V methodologies and compliance expectations
Ability to manage deliverables, timelines, and dependencies in a regulated product environment
Company
Established Search
Established Search is a global executive search firm focused on providing talent solutions across a broad range of job functions.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase