Engineer Senior - Calsoft Labs
Thousand Oaks, CA 91320
About the Job
REMOTE - expectation is that candidate would adhere to pacific coast time zone.
Or local candidates.
Please have candidate elaborate on their backgrounds with Requirements Authoring Tool such as DOORS, 3DS Requirements Mgmt (Dassault), Requisite Pro etc
Sr level role. Must have experience in the Biotech, pharma, med device industry. must have systems engineering background for at least 5 years candidate. Great communication can lead meetings and work screens. Must have: Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, 3DS (Dassault), Requisite Pro, or other similar requirements management software. Nice to have: Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts.
The Systems Engineer (SE) works as part of cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of a combination product development program. The SE understands and captures the user needs into system requirements and participates in the functional decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied, identifies technical risks and assists risk retirement activities on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.
Responsibilities: - Work cross-functionally with individuals and project teams in Marketing, Operations, and Development - Create and assess product requirements to determine technical coverage and proper integration different subsystems. - Create and execute to project plans and schedules - Develop, execute, and review requirements documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Skills: - BS in Engineering and previous experience in a medical device industry - 10 years current experience with engineering processes and procedures.
Preferred Qualifications:
" 6+ years of progressive experience as an engineer or scientist within the appropriate field of study (Systems Engineering)
" Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
" Experience in combination product development.
VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!
Or local candidates.
Please have candidate elaborate on their backgrounds with Requirements Authoring Tool such as DOORS, 3DS Requirements Mgmt (Dassault), Requisite Pro etc
Sr level role. Must have experience in the Biotech, pharma, med device industry. must have systems engineering background for at least 5 years candidate. Great communication can lead meetings and work screens. Must have: Strong background in documenting requirements and providing traceability documentation for FDA Approval - DOORS, 3DS (Dassault), Requisite Pro, or other similar requirements management software. Nice to have: Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts.
The Systems Engineer (SE) works as part of cross-functional program teams to deliver the technical content, performance, intellectual property and quality deliverables of a combination product development program. The SE understands and captures the user needs into system requirements and participates in the functional decomposition and allocation to subsystems. The SE ensures that the quality targets are satisfied, identifies technical risks and assists risk retirement activities on the program. The SE maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.
Responsibilities: - Work cross-functionally with individuals and project teams in Marketing, Operations, and Development - Create and assess product requirements to determine technical coverage and proper integration different subsystems. - Create and execute to project plans and schedules - Develop, execute, and review requirements documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
Skills: - BS in Engineering and previous experience in a medical device industry - 10 years current experience with engineering processes and procedures.
Preferred Qualifications:
" 6+ years of progressive experience as an engineer or scientist within the appropriate field of study (Systems Engineering)
" Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
" Experience in combination product development.
VERY IMPORTANT NOTE: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!!
Source : Calsoft Labs