To Apply for this Job Click Here
Systems Configuration Management Engineer
Day to Day Responsibilities
Must Haves:
- Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment.
- Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards.
- Jama Connect Proficiency: Hands-on experience using Jama Connect tool to manage requirements management and traceability.
- Systems Engineering Background: Demonstrated understanding of systems engineering principles in HW and SW, including requirements management, system architecture, and verification planning.
- Communication and Collaboration: Strong communication and collaboration skills to effectively interact with cross-functional teams and senior management.
Responsibilities:
- Develop and Maintain System Compatibility Matrix: Design, implement, and maintain a comprehensive system compatibility matrix that clearly outlines the compatible hardware and software versions across all products and platforms.
- Maintain Configuration Documentation: Create and maintain accurate product configuration documentation, including BOMs, ECOs, and PDM/PLM system data, reflecting the current product status.
- Lead Configuration Change Control: Evaluate, approve, and document all proposed configuration changes, coordinating with relevant teams and leading Change Control Board meetings.
- Ensure Regulatory Compliance: Ensure all product configurations adhere to FDA regulations, ISO 9001, ISO 13485, and other applicable standards.
- Collaborate Across Teams: Work closely with engineering, regulatory, quality, and manufacturing teams to guarantee seamless configuration management and address integration issues.
- Drive Process Improvement: Continuously evaluate and improve configuration management processes and tools, providing training to stakeholders on best practices.