Sr Systems Engineer-MFG Process 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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Hema Malini at

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Title: Sr Systems Engineer-MFG Process
Location: San Diego, CA
Duration: 5 Months

Job Description
Responsibilities:
Collaborate with Systems Engineers, Operations, Quality, Regulatory, design teams to analyze existing product documentation (G7, Stelo) and identify gaps in requirements traceability all the way to manufacturing.
Develop and maintain comprehensive traceability matrices linking design inputs, design outputs, and manufacturing processes.
Define and document manufacturing requirements based on design requirements, specifications and performance criteria.
Participate in design reviews and provide input on manufacturability and testability.
Support the development of process control plans and inspection procedures.
Identify and propose solutions to address gaps and inconsistencies in requirements and processes.
Work with cross-functional teams (design, manufacturing, quality) to ensure alignment on requirements and processes.
Provide training and guidance to other team members on requirements management and traceability best practices.

Must Haves:
1. Proven experience tracing high-level design input requirements to manufacturing process controls.
2. Expertise in requirements elicitation, analysis, and management using INCOSE Requirements standards.
3. Proficiency with Jama Connect requirements management tools.
4. Strong understanding of product development lifecycle, from concept to manufacturing.
5. Excellent communication and collaboration skills.

Required Skills (top 3 non-negotiables):
1. INCOSE Systems Engineering Handbook knowledge and practical application.
2. Experience writing clear, concise, and verifiable requirements technical HW, SW, Process controls.
3. Demonstrated ability to analyze complex systems and identify key traces from production to manufacturing requirements and dependencies.

Preferred Skills (nice to have)
Experience with statistical analysis and data interpretation
Experience with CGM technology or other medical device development
Familiarity with ISO 13485, FDA 21 CFR Part 820 and other relevant regulatory standards

Education Requirements:

B.S. in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related field. 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.

Hardware Skills Required:
Experience with hardware testing equipment is a plus, specifically related to CGM devices. Understanding of hardware architecture, interface specifications, and system-level design.

Required Certifications**:
CSEP (Certified Systems Engineering Professional) or ASEP (Associate Systems Engineering Professional) preferred.

What other business units will this person interact with?
System Engineers, Quality, Regulatory, SW VandV test teams etc.

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.