Lead Software Engineer

Summary

Join Foresight Diagnostics as a Lead Software Engineer and lead a team in developing and implementing innovative software solutions for our molecular diagnostics products. You will collaborate with cross-functional stakeholders, ensuring on-time and on-budget delivery. The ideal candidate possesses systems engineering experience in molecular diagnostics or medical devices, understanding regulatory requirements. This role involves managing a team, ensuring software component integration, and data management for robust diagnostic solutions. The position is full-time with standard business hours, but flexibility is needed. You will report to the Senior Director of Systems Engineering.

Requirements

• Bachelor’s or Master’s degree in Software Engineering, Biomedical Engineering, or a related field
• 10+ years of software engineering experience (equivalent to Principal Engineer/Software Engineer VI) in new development within the molecular diagnostics, medical device or related industry
• 2+ years leadership experience with direct reports, management of remote teams preferred
• Proven track record of leading engineering teams and managing complex projects
• Deep understanding of regulatory requirements, including CLIA, FDA, ISO 13485, 21 CFR Part 820, and IEC 62304
• Experience with Cloud technologies, AWS and GCP
• Strong software and data structure design, development, and architecture experience
• Strong knowledge of system design, integration, and validation processes
• Adaptable to fast-paced, dynamic work environments and shifting demands
• Highly collaborative, promotor of high functioning teams and an effective communicator
• Familiarity with software validation practices, quality systems, and compliance requirements to include ISO 13485, ISO 27001, IEC 62304, CMMI
• Experience working in a regulated domain
• Ability to understand and communicate needs and requirements for cloud-based execution and storage infrastructure

Responsibilities

• Lead a team of Software Engineers, fostering a collaborative and innovative work environment while balancing autonomy between the team and stakeholders
• Sustain the system engineering principles defined for your team by the Senior Director of Systems Engineering in alignment with the company’s goals and regulatory requirements
• Collaborate with inter-departmental owners including R&D, Quality, Regulatory, and Clinical to ensure cohesive product development and operations
• Make decisions related to technical oversight with the team, including DevOps, coding, and quality assurance practices
• Develop people through effective performance management and ongoing feedback, rewarding initiative and time management
• Drive collaborative group reviews of architectural design with the goal of facilitating an autonomous process with fun and healthy debate
• Promote collaboration and knowledge-sharing between engineers to mitigate wisdom-siloing and participates as an active, hands-on engineer to develop prototypes, validate proof-of-value options, develop new features, and foster continuous improvement
• Ensure the software development process produces robust, scalable and reliable deliverables
• Motivate quality focused software delivery, including new build and implementation of software
• Work with product owners and the PMO to assist with product roadmaps
• Evangelize software standards and best practices, guiding the design of systems and the relevance of development analysis
• Ensure all software components comply with relevant regulatory standards such as FDA’s 21 CFR Part 820 (Quality System Regulation) and IEC 62304 (Medical Device Software Lifecycle Processes)
• Drive Software Engineers to execute robust validation and verification processes, ensuring documentation and testing meet stakeholder and regulatory requirements
• Ensure the Software Development Life Cycle (SDLC) frameworks selected to meet the needs of our diagnostic systems are being adhered to
• Establish and maintain build and release pipelines, ensuring automated, efficient, and reliable software delivery
• Delegate or coordinate and execute release management and implement contingency measures in response to release management scenarios
• Juggle multiple tasks and fulfill ad-hoc requests based on priority
• In collaboration with the Senior Director of Systems Engineering, oversee the software development process, managing stakeholder satisfaction through seamless integration of software components and the flow of data in alignment with stakeholder requirements
• Track, monitor and report on system performance, reliability, and scalability metrics to guide data driven decision making
• Under the guidance of the Senior Director of Systems Engineering, drive continuous improvement initiatives for software process optimization, reliability, and compliance
• Foster a culture of innovation, autonomy, and quality within the systems engineering team
• Evaluate and implement new technologies and methodologies to optimize business efficiency

Preferred Qualifications

• Knowledge of bioinformatics and data analysis tools, preferred
• Knowledge and experience medical device cybersecurity, preferred

Benefits

• Paid vacation
• Sick time
• Parental leave (if applicable)
• Medical, dental, vision, life, disability coverage
• Flexible spending accounts
• 401k with company match
• Equity
• Bonus offerings
• Professional development of our employees
• Upward mobility within the company for high performing employees