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Mobia Medical is a commercial-stage medtech company delivering breakthrough stroke recovery solutions. The company's Vivistim® Paired VNS™ Therapy is the first and only FDA-approved implantable solution designed to improve function in chronic ischemic stroke survivors with moderate to severe upper limb impairments.
The Principal Software Engineer will play a key technical leadership role in the development and support of software used with the Vivistim® Paired VNS™ Therapy system. Reporting to the Vice President of Product Development, this individual will lead and contribute to software development across the full product lifecycle, including new product development, enhancements and maintenance of existing products, and software supporting manufacturing processes.
This is a highly collaborative role that works with Quality, Operations, Regulatory, Marketing, and Sales, as well as with external design partners and clinicians. The Principal Software Engineer will help translate product and customer needs into effective software solutions while ensuring development activities meet design controls, applicable standards, and regulatory requirements.
Key responsibilities include:
- Lead and actively participate in software development projects throughout the full lifecycle, from early concept through production transfer
- Develop and support design control deliverables, including software requirements, project schedules, resource requirements, software-related hazard analyses, software FMEAs, verification and validation, and production transfer activities
- Lead the maintenance and enhancement of existing software devices and systems, including software updates and technical evaluation of software-related field feedback and complaints
- Direct software design initiatives and develop specifications based on product, marketing, and customer requirements for Implantable Pulse Generator Programmers, handheld device applications, and cloud-based services
- Identify, engage, and manage external suppliers and development partners supporting software development and manufacturing projects
- Provide technical software support for product manufacturing, including the development and validation of software deployment and testing processes
- Apply engineering and medical device industry expertise to help shape strategic plans for new product development and enhancements to existing products
- Prepare technical product reports by collecting, analyzing, and summarizing information and trends related to products and internal systems
- Provide technical leadership, supervision, and mentorship to software engineers and other technical personnel, including external contractors
- Collaborate cross-functionally to ensure software solutions meet customer needs while complying with applicable design controls, standards, and regulatory requirements
REQUIREMENTS:
Required Qualifications:
- Bachelor's degree in Software Engineering, Electrical Engineering, or a related discipline from an accredited university
- 7+ years of experience developing software applications for medical devices, or an equivalent combination of relevant education and experience
- Demonstrated career progression with increasing responsibility, including technical leadership of software development projects
- Strong knowledge of the IEC 62304 medical device software development lifecycle
- Experience developing, validating, and documenting non-product software tools
- Proficiency with software version control and issue-tracking systems
- Strong technical problem-solving skills with the ability to work effectively across multiple functions
- Demonstrated leadership skills with the ability to establish credibility, lead by example, and mentor other technical professionals
- Ability to adapt to changing business priorities and work effectively in a collaborative environment
Preferred Qualifications:
- Advanced degree in Software Engineering, Electrical Engineering, or a related discipline
- Experience developing software user interfaces and partnering directly with end users to gather feedback and evaluate usability
- Experience with multiple programming languages, including C#, Python, SQL, JavaScript, C++, Java, Swift, and/or Kotlin
- Cloud application development experience, including Azure or AWS web applications used for data storage, processing, and user interfaces
- Experience developing mobile applications for iOS and/or Android
- Experience meeting medical device cybersecurity design, process, testing, and documentation requirements, including FDA premarket and post-market cybersecurity guidance
