Associate Director Software Engineering - Biotech Startup

We are a stealth-mode personalized cancer diagnostics and disease monitoring company focused on molecular genetic analysis of circulating tumor DNA (ctDNA). Our proprietary product offering which we intend to launch in 2024 has the potential to disrupt the market and hugely improve cancer medicine.

This is an onsite full-time position with potential for hybrid flexibility (1-2 days/week).

Reasons to Work for Us:

• The opportunity to join a team that is developing and optimizing cutting-edge workflows for genomic diagnostics.
• As an early employee of the RTP site you will be involved in every aspect of the business and help set the direction/culture as we grow.
• You will be given the autonomy and resources to deliver to the highest level.
• All the perks of a start-up – highly competitive salaries, team dinners/socials, flexible working, flat structure, and a dynamic work environment.

Key Responsibilities:

• Develop and execute a strategic vision for our full order-to report software stack (CRM, Portal, LIMS, etc.) in alignment with the company's overall mission, objectives, and long-term goals.
• Oversee the entire software development life cycle, including requirements analysis, design, implementation, testing, deployment, and maintenance of all enterprise applications (CRM, LIMS, Portal, etc.).
• Actively develop the current team and recruit diverse high performers who deliver high-quality work and inspire others to do the same. Foster a culture of technical excellence and service ownership.
• Ownership in building and operating the infrastructure, deployment, monitoring, and maintenance of enterprise software applications.
• Build and promote quality-driven culture in delivering COTS based LIMS Platform, Service oriented architecture and cloud-based API integration platforms.
• Integrate LIMS and other enterprise systems and services to create seamless business processes.
• Collaborate closely with cross-functional teams, including R&D, Quality, Clinical Operations, and Regulatory, to ensure seamless integration of lab informatics systems with other business processes and regulatory requirements.

Ideal Candidate Qualifications:

• 10+ years of experience in software engineering, with a focus on informatics, LIMS, CRM, or related systems.
• B.S or higher degree in Computer Science, Engineering, Bioinformatics, or a related study or equivalent project experience.
• You are fluent in a wide variety of programming concepts, disciplines, tools, environments (such as FreeRTOS, Linux, Windows, and cloud), languages (most notably C/C++ and Python), and have the ability to quickly acquire expertise and apply as needed.
• Experience working in a regulated environment (CLIA, CAP, HIPAA, SOX, SOC2, 21 CFR Part 11, ISO 13485, IEC 62304, and other required regulations) is desired.
• Strong understanding of the molecular diagnostics industry and regulatory landscape with experience in developing RUO, IUO, LDT, and IVD software.
• Proven experience leading and managing software engineering teams with a track record of delivering complex, high-quality solutions.
• Experience in Systems/Applications automation in 24x7 Production Service environments.
• Experience in development and operation of software products in the healthcare and life science industries. This includes securing protected healthcare information (PHI) in various environments.
• Experience operating on public cloud (both PaaS and IaaS offerings) and experience with Continuous Integration and Continuous Delivery concepts.

Primary Location: Onsite 2-3 days/week in Morrisville, North Carolina.

Hours & Travel: This is a full-time position. Minimal travel may be required to our two other sites (Europe, Massachusetts).

Salary: ~$180-240K base. Compensation depends on multiple factors including but not limited to education, relevant experience, skills, and market demand.