Job Title: Systems Configuration Management Engineer

Location: San Diego, CA

Duration: 5 Months contract

Pay Range: $60/hr-$70/hr on W2

Description:

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 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.

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.

Required Skills (top 3 non-negotiables):

1. Proven experience applying configuration management principles and best practices in a regulated product development setting.

2. Strong understanding of mobile and wearable application architecture.

3. Jama Connect Requirements Management tool and traceability

Preferred Skills (nice to have)

1. Experience with medical device software development.

2. Familiarity with CGM technology.

3. Familiarity with software configuration management tools and processes (e.g., Git, Jenkins)

Education Requirements:

• Minimum Bachelors + experience, MS preferred

Required Testing:

• May include technical assessments related to configuration management principles, PDM/PLM software proficiency, and systems engineering fundamentals.
• Personality assessments to evaluate cultural fit.

Software Skills Required:

• 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).

Required Certifications: None explicitly required. Industry-recognized certifications related to configuration management (e.g., CCMP) or systems engineering (e.g., INCOSE CSEP) are a plus.

Benefits Info

Russell Tobin offers eligible employee’s comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance and employee discounts with preferred vendors.