Overview
On Site
BASED ON EXPERIENCE
Contract - Independent
Contract - W2
Contract - 12+ mo(s)
Skills
FIRMWARE ENGINEER
EMBEDDED SOFTWARE
FIRMWARE
EMBEDDED
MEDICAL DEVICE
MEDICAL EQUIPMENT
FDA REGULATED
IMPLANTABLE DEVICES
IMPLANTABLE
ISO
BLE
BLUETOOTH
NFC
WIRELESS
WIRELESS COMMUNICATION
ANDROID
IOS
JAVA
SWIFT
KOTLIN
MOBILE APPLICATION
DART
MOBILE OPERATING SYSTEM
Job Details
Software Engineer III
Qualifications:
Preferred:
If this job is a match for your background, we would be honored to receive your application!
Job Summary: Talent Software Services is in search of a Software Engineer for a contract position in Irvine, CA. The opportunity will be a year with a strong chance for a long-term extension.
Position Summary: We are seeking an experienced and skilled Software Engineer to join the client's Urology team. In this role, you will be part of the evaluation, integration of software and firmware technologies for medical devices for Axonics/client's Urology products. As a technical hands-on contributor, you will execute integration activities and support software development, ensuring compliance with medical device regulations. This role requires experience with an application software development, embedded systems, android platform, test frameworks, and regulatory compliance medical device software development processes.
Primary Responsibilities/Accountabilities:
- Participate in technology evaluations, technical assessments, and validation of software architectures, embedded software, and system integration aspects of acquired implantable medical devices.
- Support software architecture, development, testing strategi,es and risk management activities for software applications
- Evaluate compliance and ensure software/firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971and other regulatory standards governing medical devices.
- Contribute to defining test strategies (Unit/Integration) and draft design verification protocols to verify software/firmware functionality post-acquisition.
- Support software/ firmware testing, debugging, and verification efforts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments.
- Identify potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies.
- Ensure acquired software meets medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance, IEC 62443.
- Collaborate with cross-functional teams, including hardware engineers, systems engineers, quality, regulatory affairs, manufacturing, and PM,O, to ensure seamless device integration.
- Establish and document software development lifecycle (SDLC) artifacts to align with internal quality management systems (QMS). Maintain thorough design documentation, traceability matrices, and SDLC artifacts for regulatory submissions.
- Provide technical inputs on low-power embedded systems, wireless communication (eg, BLE, NFC, RF telemetry), and real-time operating systems (RTOS).
- Collaborate with regulatory teams on 510(k), PMA, or CE Mark submissions involving firmware-related changes.
- Contribute to a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.
- Build Quality into all aspects of their work by maintaining compliance with all quality requirements.
Qualifications:
- B.S or M.S. in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering, or related major.
- 3+ years of experience in software development, with 1+ years in embedded or application software for medical devices.
- Sound knowledge of software engineering principles and practices.
- Knowledge of programming languages such as Swift, Java, Dart, or Objective-C and mobile operating systems and platforms such as iOS and Android.
- Experience in developing mobile applications in anFDA-regulatedd environment or other regulated industry.
- Strong C/C++ skills for programming microcontroller systems.
- Knowledge and use of OOP design principles, API design principles.
- Knowledge in low-power embedded systems, real-time operating systems (RTOS), and microcontroller-based firmware development.
- Strong time management and communication skills.
Preferred:
- Experience with mergers & acquisitions (M&A) due diligence in the medical device sector.
- Experience in risk assessment, cybersecurity, and regulatory compliance for implantable devices. Knowledge of ISO 13485 and FDA QSR is desired.
- Experience using oscilloscopes, logic analyzers, and other related tools.
- Detailed knowledge of BLE stacks and BLE API on mobile platforms
- Experience in integrating BLE embedded systems with iOS, Android, and Windows applications.
- Knowledge of PC application development in Microsoft Visual Studio (e.g, C# NET).
- Hands-on experience with secure bootloaders, cryptographic protocols, and over-the-air firmware updates for implantable devices.
If this job is a match for your background, we would be honored to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk!
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