Senior Systems Engineer, Medical Device Technical Lead (JP11791)

3 Key Consulting • Thousand Oaks, CA

2d • Onsite

About The Position

3 Key Consulting is recruiting a Senior Systems Engineer, Medical Device Technical Lead for a consulting engagement with our direct client, a leading global biotechnology company. The Systems Engineer (SE) works as part of cross-functional program teams to deliver technical content, performance, intellectual property and quality deliverables of a combination product development program. The Systems Engineer understands and captures the user needs into system requirements and participates in the functional decomposition and allocation to subsystems. The Systems Engineer ensures that the quality targets are satisfied, identifies technical risks and assists risk retirement activities on the program. The Systems Engineer maintains close interaction with customers to understand and enhance the ability to deliver on customer satisfaction through high product quality.

Requirements

• Experience in the biotechnology, pharmaceutical, or medical device industry.
• At least 5 years’ experience in systems engineering.
• Great communication skills and ability to lead meetings and work teams.
• Strong background in documenting requirements and providing traceability documentation for FDA approval DOORS Requisite Pro, or other similar requirements management software.
• Proficient in Microsoft Excel especially in writing macros in excel.
• BS in Engineering and previous experience in a medical device industry.
• 10 years current experience with engineering processes and procedures.

Nice To Haves

• Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts experience is preferred.
• Past experience in writing SOPs, Guidance & technical documents is preferred but not required
• 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.

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.
• Responsible for writing technical and guidance documents that provides guidance to team members in following design control and business processes within client.
• Develop Toolsets using Microsoft excel to enable easier on boarding of other engineers onto client processes
• Work and Lead cross functional teams in development of common practices and write technical guidance documents to enable consistency across various combination product teams.

What This Job Offers

• Career Level: Senior