Systems Engineer 3
Systems Engineer 3
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1 Vacancy
Job Description
Meghna at
Location: San Diego CA
Duration: 5 months
1. Configuration Management Expertise: Proven understanding and application of configuration management principles and best practices within a complex product development environment.
2. Medical Device Experience: Experience working within the medical device industry or other regulated sectors with knowledge of FDA regulations and ISO standards.
3. Jama Connect Proficiency: Handson experience using Jama Connect tool to manage requirements management and traceability.
4. Systems Engineering Background: Demonstrated understanding of systems engineering principles in HW and SW including requirements management system architecture and verification planning.
5. Communication and Collaboration: Strong communication and collaboration skills to effectively interact with crossfunctional teams and senior management.
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 Client CGM 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.
Drive Process Improvement: Continuously evaluate and improve configuration management processes and tools providing training to stakeholders on best practices.
- Proven experience applying configuration management principles and best practices in a regulated product development setting.
- Strong understanding of mobile and wearable application architecture.
- Jama Connect Requirements Management tool and traceability.
- Experience with medical device software development.
- Familiarity with CGM technology.
- Familiarity with software configuration management tools and processes (e.g. Git Jenkins).
Lack of demonstrable experience with configuration management in a relevant industry
Inability to articulate systems engineering concepts.
- Minimum Bachelors experience MS preferred.
May include technical assessments related to configuration management principles PDM/PLM software proficiency and systems engineering fundamentals.
Personality assessments to evaluate cultural fit.
Understand Product development lifecycle; Agile; SDLC ISO 62304
Proficiency with PDM/PLM software (e.g. Windchill Agile SAP). Microsoft Office Suite. Other software skills may be required based on specific project needs (e.g. requirements management tools configuration management databases).
- None explicitly required.
- Industryrecognized certifications related to configuration management (e.g. CCMP) or systems engineering (e.g. INCOSE CSEP) are a plus.
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full Time
