Systems Configuration Management Engineer

Genesis10 is seeking a Systems Configuration Management Engineer for a 5- month on-site contract position with a leading client in San Diego, CA. This role pays $65-70 /hour W2 based on experience.

**Please be aware to qualify for this position, you must be a Greencard holder or US Citizen**

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 Dexcom 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.
• 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.

Requirements:

• 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.
• 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
• Minimum Bachelors + experience, MS preferred
• 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).

Preferred Experience:

• Experience with medical device software development.]
• Familiarity with CGM technology.
• Familiarity with software configuration management tools and processes (e.g., Git, Jenkins)

Genesis10 - Contract & Perm/Direct Hire Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.

For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10:

* Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years.

* The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years.

* Access to an experienced, caring recruiting team (more than 7 years of experience, on average.)

* Behavioral Health Platform

* Medical, Dental, Vision

* Health Savings Account

* Voluntary Hospital Indemnity (Critical Illness & Accident)

* Voluntary Term Life Insurance

* 401K

* Sick Pay (for applicable states/municipalities)

* Commuter Benefits (Dallas, NYC, SF)

For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all our available career opportunities, please visit us at our website.

Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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