POSITION SUMMARY

The Software Engineering Leader will lead our software development and sustaining activities for our drug delivery systems. Reporting directly to the VP of R&D, the Software Engineering Leader will ensuring the successful delivery of software solutions from concept through maintenance. This individual will also oversee an external team of electrical engineers for electrical hardware development. This role requires strong leadership skills, technical expertise in software development, and a deep understanding of regulatory requirements for medical device software. The Software Engineering Leader will play a crucial role in driving innovation, maintaining software quality, and ensuring compliance with relevant standards.

ESSENTIAL FUNCTIONS

Oversee the design, development, testing, and deployment of software solutions for drug delivery systems.
Ensure adherence to software development lifecycle (SDLC) best practices and regulatory requirements (IEC 62304).
Drive continuous improvement initiatives in software development processes and practices.
Collaborate with cross-functional teams including hardware engineers, electrical engineers, and regulatory affairs to deliver integrated solutions.
Manage and prioritize software sustaining activities, including maintenance, updates, and bug fixes for existing software products.
Coordinate with cross-functional teams to address software-related issues and implement corrective actions.
Ensure compliance with FDA regulations (e.g., 21 CFR Part 820, 21 CFR Part 11) and international standards (e.g., ISO 13485) for medical device software.
Manage software quality documentation, including software requirements specifications, design documents, and risk management files.
Collaborate closely with Product Management to align software development efforts with product roadmaps and customer requirements.
Communicate effectively with internal stakeholders, external suppliers, and regulatory bodies to support regulatory submissions and audits.

POSITION QUALIFICATIONS

Experience and Education

Minimum B.S. degree in Computer Science, Software Engineering, or a related field (M.S. preferred).
Minimum 7 years of experience in software development, with at least 3 years in a leadership or managerial role.
Proficiency in software development methodologies and tools (e.g., Agile, Git, JIRA).
Experience with embedded software development, real-time operating systems, and IoT technologies.
Strong understanding of software architecture, design patterns, and best practices.
Familiarity with software verification and validation processes for medical devices.
Deep knowledge of FDA regulations and standards applicable to medical device software (e.g., IEC 62304).
Experience in managing software documentation under regulatory scrutiny.

Skills and Abilities

Excellent organizational and communication skills.
Strong decision-making skills.
Ability to work independently and ability to manage multiple priorities.
Hands-on, driven work ethic and entrepreneurial spirit.
Willing and able to travel occasionally for project-related meetings (typically less than 10%).

The Software Engineering Leader will play a pivotal role in advancing our drug delivery systems through innovative software solutions while ensuring compliance with regulatory requirements and maintaining high standards of software quality. If you are passionate about software engineering leadership and have the required qualifications, we invite you to apply and join our team dedicated to making a difference in reducing mortality, morbidity, and the cost of care associated with musculoskeletal infections.

Osteal Therapeutics jobs

Software Engineering Leader