What are the responsibilities and job description for the Sr Systems Engineer-MFG Process position at divihn.com?
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists :
Hema Malini at 630 847 0275
Meghna at 224 369 4230
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 :
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 V&V test teams etc.
