Director of Engineering- Software Development in Madison, Wisconsin at MERIT CRO Inc

MERIT is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We're committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities

The Director of Engineering will lead the development team responsible for building and maintaining the EXCELSIOR platform and other MERIT customized applications. This role encompasses overseeing the technical direction of the product, managing the software bill of materials (SBOM), and ensuring the professional growth of the engineering staff. The Director will work closely with product management, quality assurance, and other key stakeholders to deliver high-quality, regulatory-compliant software solutions. The Director is responsible for aligning the development processes with business objectives and fostering a collaborative and innovative engineering culture.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)

• Extensively understand MERIT proprietary products and conduct of clinical trials in sufficient detail to be able to confidently discuss and manage tasks with Product Operations and Management (POM), development, and validation team members

• Comply fully with MERIT policies and Standard Operating Procedures (SOPs)

• Team Leadership & Management:

• Provide technical leadership and management of the engineering team, including overseeing day-to-day activities, setting clear goals, and fostering a positive and high-performance work environment.
• Mentor and guide team members to ensure both personal growth and alignment with company objectives.
• Interview and contribute to final hiring decision of new staff within department
• Monitor employee performance and routinely provide constructive feedback and coaching

• Software Development Lifecycle Management:

• Oversee all phases of the software development lifecycle, ensuring timely delivery of high-quality, compliant, and secure software.
• Maintain best practices for design, development, testing, and deployment while maintaining strong focus on quality and regulatory adherence (e.g., FDA 510(k), 21 CFR Part 11).

• Software Bill of Materials (SBOM) Oversight:

• Manage and maintain the SBOM, ensuring transparency and control over third-party software components, dependencies, and licenses.
• Ensure that all open-source and third-party software complies with security expectations of the organization.

• Collaboration with Cross-functional Teams:

• Work closely with product management, validation, and quality assurance regulatory teams to align development initiatives with business needs and regulatory standards.
• Ensure effective communication and collaboration between departments to meet project goals.

• Career Path Development for Engineers:

• Develop and implement a career path framework for developers, providing clear growth opportunities and structured performance reviews.
• Ensure regular professional development, including training and mentorship, to help engineers advance their technical skills and leadership abilities.

• Technical Strategy & Roadmap Execution:

• Partner with product leadership to define and execute the technical roadmap. Make strategic decisions around technology stack, architecture, and long-term platform evolution to ensure scalability, security, and regulatory compliance.

• Resource Planning & Allocation:

• Manage development resources to ensure optimal productivity, while balancing short-term and long-term product goals.
• Ensure that the team is appropriately staffed and has the skills required to meet project demands.

• Innovation & Continuous Improvement:

• Lead the team to explore new technologies and methodologies.
• Continuously seek opportunities for process improvements.

• Risk Management & Issue Resolution:

• Proactively identify risks related to technical challenges, regulatory compliance, and delivery timelines.
• Implement mitigation strategies and resolve issues that may impact project success.

• Budget & Vendor Management:

• Manage the engineering budget, ensuring that spending aligns with project goals and company financial targets.
• Work with external vendors, such as Microsoft Azure services, as needed to acquire tools, technologies, and services essential for development.

Other:

• Comply fully with company policies and SOPs

• Other responsibilities may be assigned as required

The following are the essential functions of the position but are not all-inclusive.

Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.

Demonstrates a commitment to maintain safe, clean and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must possess experience managing a regulatory-compliant software platform, particularly in the healthcare or clinical trial

sectors.

Additional skills for success:

• Experience with clinical imaging trial platforms, healthcare technology, and DICOM standards.

• Knowledge of FDA regulatory compliance, including FDA 510(k) and 21 CFR Part 11.

• Proficiency in management of Microsoft Azure Services

Education and Experience:

Minimum of a bachelor's or master's degree in computer science, engineering, or related field.

A Minimum of 10 years of software development experience with at least five (5) years in a leadership role managing development teams.

Other Skills and Abilities:

Strong interpersonal and organizational skills, excellent attention to detail, ability to follow direction, assess company needs and work independently. Have a strong knowledge of software development methodologies, cloud technologies, and DevOps practices. Have a deep understanding of software architecture, design patterns, and scalability. Excellent leadership, mentorship, and communication skills, with the ability to motivate and develop a high-performing engineering team. An ability to troubleshoot new applications and ability to learn company specific software is a must. Project a professional attitude and image appropriate for the work environment.

Ability to participate and contribute in a team environment. Oral and written communication is clear, concise, and effective. Distinguish between technical and eneral end-user communication.

Licenses or Certifications Required:

None.

Benefits Offered:

401(k) Retirment Plan, Dental insurance, Disability insurance, Health insurance, Life insurance, Paid time off

Vision insurance

MERIT CRO, Inc. is an equal opportunity employer, and we are committed to hiring a diverse and talented workforce. It is the employment policy and practice of MERIT CRO, Inc. to recruit and hire qualified employees without discrimination based on race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, national origin, ancestry, citizenship status, age, mental and physical disability, pregnancy, medical condition, genetic information, political affiliation, union membership, status as a parent, marital status, military or veteran status, or other classes protected by applicable law, and to not discriminate concerning compensation and opportunities for advancement, including upgrading, promotion, and transfers. We will provide reasonable accommodation to qualified individuals throughout the application, interviewing, and employment process. If you require reasonable accommodation, please contact us.