Position Summary

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

Responsibilities

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

Must Have

  • Technical experience: C++ hands-on experience (Linux would be nice as well)
  • Modern SDLC: Experience with Agile in a DevOps environment
  • Quality & Cybersecurity: Proven track record for high quality and secure software
  • Communication & Ownership: Open and transparent communication as well as self-driven person

Nice To Have

  • International experience
  • Platform Development

Qualifications

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

The annual base salary range for this role is currently $170,000 range to $210,000 range. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.

About Werfen North America

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong.

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