Sr Systems Engineer-MFG Process
Sr Systems Engineer-MFG Process
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1 Vacancy
Job Description
Hema Malini at
Location: San Diego CA
Duration: 5 Months
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 crossfunctional 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.
1. Proven experience tracing highlevel 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.
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.
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
May include technical assessments related to configuration management principles PDM/PLM software proficiency and systems engineering fundamentals.
Personality assessments to evaluate cultural fit.
Experience with hardware testing equipment is a plus specifically related to CGM devices. Understanding of hardware architecture interface specifications and systemlevel design.
CSEP (Certified Systems Engineering Professional) or ASEP (Associate Systems Engineering Professional) preferred.
System Engineers Quality Regulatory SW V&V 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 MidWest 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.
Employment Type
Full Time
