Systems Engineer 3 at DivIHN Integration Inc

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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Title: Systems Engineer 3
Location: San Diego, CA
Duration: 5 months

Job Description :

Must Haves:
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: Hands-on 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 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 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.

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.

Required Skills (top 3 non-negotiables):

• 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.

Preferred Skills (nice to have)

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

Disqualifiers/ Dislikes on Resumes:
Lack of demonstrable experience with configuration management in a relevant industry
Inability to articulate systems engineering concepts.

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.

About us:

DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West 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.