Position Summary:

Under the supervision of the Software Director, responsible for all aspects of software development concerning one or more product lines.

Key Accountabilities

Essential Functions:

• Manages reporting development group functionally.
• Maintains software development job descriptions.
• Manages hiring process for software development staff.
• Manages performance reviews.
• Manages an external partner software contracting firm.
• Team training, mentoring and career development as appropriated. Monthly one on one meeting with direct reports and technical leads.
• Overall resource and development role allocation across projects based on project milestones and resource availability.
• Oversees software development across different Software projects, for all Software deliverables and throughout the entire development cycle.
• Ensures software is perfectly documented, designed and implemented according to standard engineering methods, techniques and best industry practices.
• Exploits synergies (e.g. Code reuse, platform paradigm) and extends best development practices across projects.
• Defines consistent software development methods and procedures across projects and ensures they are properly documented (e.g. SOPs) and implemented.
• Responsible for managing continuous software development improvement efforts (both technical and process related) to continually shorten development cycles, improve quality and update SOPs accordingly in conjunction with the SQA Manager.
• Defines development deliverables and templates (Software development plans, software requirements, software architecture, software designs, unit testing,etc) across projects and ensures related artifacts are properly scheduled, implemented and reviewed.
• Ensures usage of state of the art development tools and consistent use across projects.
• Develops, executes and maintains a continuous integration and unit test program to be the primary driver for builds and regression testing of code when changes are implemented and before they are released to test.
• Leads software risk analysis and ensures that risk mitigations at software level are effectively documented and implemented.
• Status reporting and detailed scheduling supporting different product development projects, delegating to technical leads as needed.
• Fulfills the role of development coordinator for a development project or program of projects.
• Fulfills the role of technical lead as needed.
• Ensures that all software development activities and deliverables comply with the FDA QSR, ISO 9001 and satisfy Werfen processes and procedures

Budget Managed (if applicable):

• N/A

Internal Networking/Key Relationships:

• Interfaces with Project/Program Management
• Software Testing
• Systems Engineering
• Electrical Engineering and the Software Quality Manager
• TBD based on company needs

Skills & Capabilities:

• Leadership
• Developing Direct Reports and Others
• Time Management
• Written and Oral Communications

Minimum Knowledge & Experience Required for the Position:

• Bachelor's degree in information technology or the equivalent combination of related training, proficiency and experience.
• Minimum 5 years of industry experience managing software development teams and leading software projects.
• Exposure to the life sciences and/or highly regulated industry domain.
• Comprehensive knowledge of software development theory, practice, strategies and tactics required.
• Knowledge of and experience with iterative and waterfall software development lifecycle methodology's required.
• Experience with test-driven development, continuous Integration and other agile practices.
• Knowledge of and experience with technologies supporting software development management (e.g. DOORs), issue management (e.g. Synergy Change) and configuration management (e.g. Accurev) Comprehensive knowledge of Quality standards such as ISO 9000/9001, 21 CFR Part 820 FDA Quality System Regulations and CFR 21 Part 11 regulations.

International Mobility Required:

• No

Travel Requirements: 

• <5% of time