Software Development Manager

WerfenBedford, MA
73d

About The Position

Under the supervision of the Software Director, the position is responsible for all aspects of software development concerning one or more product lines. This includes managing the reporting development group functionally, overseeing the hiring process for software development staff, and conducting performance reviews. The role also involves managing an external partner software contracting firm and facilitating team training, mentoring, and career development. Monthly one-on-one meetings with direct reports and technical leads are part of the responsibilities. The position requires overall resource and development role allocation across projects based on project milestones and resource availability. The individual will oversee software development across different software projects, ensuring that all deliverables are documented, designed, and implemented according to standard engineering methods and best industry practices. Additionally, the role involves defining consistent software development methods and procedures across projects, managing continuous software development improvement efforts, and ensuring compliance with FDA QSR, ISO 9001, and Werfen processes and procedures.

Requirements

  • Bachelor's degree in information technology or equivalent combination of 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 methodologies 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.

Nice To Haves

  • International experience
  • Platform Development

Responsibilities

  • 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.
  • Facilitates team training, mentoring, and career development as appropriate.
  • Conducts monthly one-on-one meetings with direct reports and technical leads.
  • Allocates overall resource and development roles across projects based on project milestones and resource availability.
  • Oversees software development across different software projects for all deliverables throughout the entire development cycle.
  • Ensures software is documented, designed, and implemented according to standard engineering methods and best practices.
  • Exploits synergies and extends best development practices across projects.
  • Defines consistent software development methods and procedures across projects and ensures proper documentation and implementation.
  • Manages continuous software development improvement efforts to shorten development cycles and improve quality.
  • Defines development deliverables and templates across projects and ensures related artifacts are properly scheduled, implemented, and reviewed.
  • Ensures usage of state-of-the-art development tools across projects.
  • Develops, executes, and maintains a continuous integration and unit test program for builds and regression testing.
  • Leads software risk analysis and ensures effective documentation and implementation of risk mitigations.
  • Provides status reporting and detailed scheduling for 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 compliance of all software development activities and deliverables with FDA QSR, ISO 9001, and Werfen processes.
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