Systems Engineer, Biopharma/Medical Device - Remote PST (JP13467)

Job Title: Systems Engineer, Biopharma/Medical Device - Remote PST (JP13467) Location: Thousand Oaks, CA. 91320 (100% Remote) Business Unit: Systems Engineering Group Employment Type: Contract Duration: 18 months with likely extensions and/or conversion to a permanent position. Rate: $45 - $50/hour W2 Posting Date: 12/04/2024. Notes: Only qualified candidates need apply. Regular working hours PST. Candidates must have experience in requirements authoring tools such as DOORS, 3DS Requirements Management (Dassault), Requisite Pro, etc. and must be shown on resume. 3 Key Consulting is hiring! We are recruiting a Systems Engineer & Systems Requirements Expert for a consulting engagement with our direct client, a leading global biotechnology company. Job Description: Qualified candidates with either a strong Electrical Engineering, Mechanical Engineering, OR Systems/Software Engineering background need apply and will be considered!!! Senior level role. Candidate must have experience in the Biotech, pharma, med device industry. Candidate must have systems engineering background for at least 5 years. Great communication, can lead meetings and work screens. Candidate 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. Top Must Have Skill Sets: • Systems Engineering past work experience. • Past experience in writing Requirements using Requirements Management Tool such as DOORS, 3DS Requirements Mgmt (Dassault) etc • Proficient in Microsoft Excel especially in writing macros in excel and or SmartSheet. Day to Day Responsibilities: • Responsible for writing technical and guidance documents that provides guidance to team members in following Requirements Management Toolset such as 3DS. • Develop Toolsets using Microsoft excel or SmartSheet 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. Candidate will 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. Basic Qualifications: • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience • BS in Engineering and 5 years’ 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. Red Flags: • No Degree • No Systems Engineering Background Why is the Position Open? Planned Project Interview Process: • Video Conference with Hiring Manager. • After initial Interview a panel interview (Video Conference) with additional hiring team. • Candidate must be comfortable in Web-Cam / Video Conference interview screening. We invite qualified candidates to send your resume to [email protected]. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. Apply tot his job