Job Description

• Candidates must have experience in the biotechnology, pharmaceutical, or medical device industry.
• Candidates must have at least 5 years’ experience in systems engineering.
• Candidates must have great communication skills and can lead meetings and work teams.
• Candidates must have strong background in documenting requirements and providing traceability documentation for FDA approval
  • DOORS
  • Requisite Pro, or other similar requirements management software.
• Practical experience in configuration management and change control process/requirements, CCB (change control board), CIT (change implementation team) concepts experience is preferred.

• 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.

• Systems Engineering past work experience.
• Ability to communicate effectively and lead large teams in development of technical deliverables required for design control deliverables.
• Past experience in writing SOPs, Guidance & technical documents is preferred but not required
• Proficient in Microsoft Excel especially in writing macros in excel.

• 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.

• BS in Engineering and previous experience in a medical device industry.
• 10 years current experience with engineering processes and procedures.

• 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.

• No degree
• No systems engineering experience

• Video Conference with Hiring Manager.
• Selected candidates would then have a panel 1:1 video conference with additional team members.
• Candidate must be comfortable with video (webcam) online interview process.