JOB SUMMARY

As a configuration management specialist, you will create, plan, implement, and maintain configuration management strategies, policies, tools, and procedures. The responsibilities of the Configuration Management Specialist include:

• Architect a robust variant and configuration management strategy for complex medical device systems including software branch support for multiple fielded versions.
• Create and maintain a configuration management plan and procedures.
• Implement, manage, monitor, and control the configuration of medical device software, hardware, disposables, labeling, and systems throughout the product lifecycle.
• Train the global R&D organization to properly apply configuration management using a requirement management tool.

ESSENTIAL DUTIES

Architect, implement, and maintain a robust configuration management strategy. Meet the following criteria:

• Demonstrate a solid understanding of configuration management principles, fundamentals, architectures, protocols, standards, tools, and methodologies.
• Support well-organized large-scale development, maintenance, and release effort across all medical device functional areas.
• Take ownership of planning, implementing, and monitoring the configuration management system for the R&D organization.
• Enforce regulatory criteria, standards, product development principles, and engineering best practices.
• Support configuration items and their attributes, relationships, dependencies, versions, revisions, and releases including software branch support for multiple fielded software versions.
• Anticipate future configuration management challenges and develop a strategy to effectively prevent or minimize negative outcomes.
• Allow development to proceed simultaneously along more than one path while maintaining the relationships between the different paths. Establish and enforce baseline integrity.
• Maintain all current and future variants of a product lifecycle. Simultaneously manages several in-parallel, in-flight projects across several domains.
• The configuration management strategy must support engineering analysis of proposed design changes to determine the effect on the overall system.
• The configuration management strategy must assist engineers in identifying and implementing measures to mitigate risks associated with configuration changes.
• Configuration items for a given product may include all system domains including hardware, disposables, labeling, and software (i.e., firmware, embedded software, interfacing software applications).
• Design and establish configuration management documentation and processes.
• Create training materials and conduct training sessions to raise awareness of configuration management among employees including global partner teams.
• Communicate and collaborate with stakeholders to explain and interpret policies, practices, and procedures.
• Be the central interface to align different development projects.
• Identify opportunities for continuous process improvement and optimization within the configuration management framework.
• Conduct configuration audits to verify compliance with regulations and to ensure the integrity and completeness of product documentation.
• Ability to pinpoint and resolve common challenges including managing complex and dynamic configurations, dealing with frequent and unplanned changes, ensuring compliance with policies and regulations, coordinating and integrating configuration management activities with other quality processes, and keeping up with evolving technologies.
• Collaborate effectively with cross-functional teams (both non-R&D and R&D) to support process improvements and strategic initiatives to achieve internal customer requirements, design control objectives, and regulatory standards.

Provide clear solutions to complex, ambiguous problems.

Consistently deliver high-quality results and meet deadlines.

Take initiative, full ownership of responsibilities, and personal accountability to drive progress and achieve aggressive goals.

Continuously seek to expand knowledge and skills.

Communicate effectively, collaborate well with others, maximize productivity, and align work with the organization's strategic goals.

MINIMUM QUALIFICATION REQUIREMENTS

Education

Bachelor of Science degree in Engineering or other science (e.g. chemistry, physics, biology, computer science).

Experience

Minimum 8 years of experience in variant and configuration management of complex systems.

Expert in requirements traceability management tools to manage requirements and traceability between requirements, design elements, test artifacts, interface controls, risk control measures, and outputs.

Experienced in use of Model Based Systems Engineering tools to manage the configurations of products maximizing the reuse of specifications, design and testing evidence.

Demonstrated success managing large complex projects across the entire lifecycle.

Skills

Extensive knowledge of the product development lifecycle, from planning and development through to release and maintenance.

Meticulous attention to detail in all tasks and projects.

Skilled in fostering open communication and collaboration, encouraging input from others and contributing to a positive team environment.

Effective presentation skills, capable of delivering technical information to both technical and non-technical audiences and adept at responding to inquiries from various stakeholders.

Superior written and verbal communication abilities, ensuring clear and effective communication of complex information across diverse audiences.

Problem-solving and analytical skills. Apply critical thinking skills to analyze problems and develop innovative solutions.

Proficient in identifying and resolving issues promptly. Make timely decisions involving appropriate stakeholders, ensuring efficient problem resolution and project execution.

Proven ability to communicate effectively both verbally and in writing, fostering strong relationships and clear understanding.

Demonstrated leadership skills, including strong interpersonal skills and the capacity to lead through influence rather than authority.

Strong listening and observational skills, able to quickly grasp audience needs and adjust communication style accordingly.

Excellent organizational and time management skills and proper prioritization, ensuring efficient workflow and deadlines consistently met.

Proactively pinpoint and take ownership of issues, including thorough follow-through to resolution.

Able to work independently with minimal oversight, demonstrating initiative and self-motivation.

Knowledge and effective use of relevant PC software applications and skills to use them effectively.

Strong work ethic characterized by dedication and reliability in team-based settings.

Knowledge of SysML using tools like CATIA Magic, PTC Modeler or Enterprise Architect is preferred