We are seeking a Software Development Lead to drive the technological strategy and execution for our medical devices and software stack. This individual will act as both a hands-on technical contributor and a team leader, guiding and inspiring a small but talented engineering team to develop cutting-edge med tech solutions. The role involves designing and developing Software in Medical Devices (SiMD), choosing the right technology stacks, configuring infrastructure, and leading the creation of scalable solutions.
The ideal candidate will possess the strategic insight to determine when to develop systems internally versus when to utilize off-the-shelf solutions. A player-coach mentality is essential, as this role requires both leading the team and actively contributing to deliverables when needed. Strong leadership skills are crucial for team-building and navigating regulatory environments. The ability to balance leadership and following direction, while prioritizing the company's objectives, is key.
Experience with ISO 13485 and IEC 62304 frameworks for medical device development is highly valuable.
Key Responsibilities:
Lead the development of software solutions that meet the company's core functional needs.
Recruit, mentor, and lead a high-performing development team, fostering a collaborative and innovative environment.
Oversee the design, implementation, and optimization of application architecture and database systems.
Ensure both the software applications and infrastructure are scalable and high-performing.
Manage in-house development and external contractors while strategically building an internal team to develop the software stack, including device, mobile app, and cloud components.
Make informed decisions about when to prioritize in-house development versus leveraging external contractors to meet project goals and deadlines.
Select and configure the right development tools, programming languages, frameworks, and cloud services to drive efficient software development.
Develop and implement technology strategies that align with the company's broader vision and goals.
Apply project management skills to oversee technology initiatives, ensuring timely and successful delivery.
Optimize resource utilization through thoughtful technology planning.
Infrastructure Design and Configuration:
Design and configure the required infrastructure for hardware, firmware, mobile apps, and cloud services.
Ensure that the infrastructure is scalable, secure, and supports the company's growth plans.
Quality Assurance and Security:
Implement FDA-compliant quality assurance processes in collaboration with QMS personnel, in accordance with IEC 62304 and ISO 13485, to ensure the reliability and performance of all technology components.
Ensure software platforms comply with cybersecurity regulations, including ISO 80001 and HIPAA.
Safeguard intellectual property and sensitive data through effective IP security management.
Lead the creation of test processes for verification and validation, in collaboration with quality management staff.
Oversee software validation and verification, ensuring regulatory compliance in documentation and testing.
Work closely with software and algorithm developers to ensure the development and deployment of compliant and robust software.
Manage risk assessment and mitigation strategies related to software and cybersecurity.
Stay up to date with changes in regulatory standards and guide the team in maintaining compliance.
Qualifications:
BS/MS in Software Engineering, Computer Science, or equivalent experience.
Proven full-stack software development experience, particularly in the medical or other regulated industries.
7+ years of experience successfully taking connected medical devices or medical software from concept to market.
Demonstrated success in creating and executing test plans, meeting software development standards, and delivering software products, especially medical device-related software.
In-depth experience with quality management systems (QMS), including design documentation control and the phase-gated development structure for medical devices.
Strong interpersonal communication, team-building, and technical writing skills.
Experience developing SiMD or SaMD in line with ISO 13485 and IEC 62304.
This is an exciting opportunity for a dynamic leader who is ready to take on the challenge of shaping the future of medical technology.