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Systems Engineer

Thousand Oaks, CA 91320

Posted: 01/15/2025 Employment Type: Contract Job Category: Scientific Job Number: 616508 Is job remote?: Yes Country: United States

Job Description

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.

Pay ranges between $40-45.60/hr based on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.