Systems Engineer

Role Summary

The Systems Engineer leads development activities within a cross-functional program team to create the technical content, performance, intellectual property, and quality results of a combination product (device/biologic) development program. They translate user needs into system requirements, perform functional decomposition and allocation to subsystems, and ensure that quality targets are satisfied. They identify technical risks and coordinate risk retirement activities, maintaining close interaction with customers to deliver high-quality products and ensure customer satisfaction.

Responsibilities

• Develop, implement, and review requirements (within an electronic requirements management system), design documents, specifications, development plans, characterization plans, verification and validation plans, and other related product development documents for assigned projects.
• Create and implement project plans and schedules.
• Create and assess product requirements to determine technical coverage and proper integration of different subsystems of combination products through consideration of the system as a whole, rather than individual components of the system.
• Work cross-functionally with individuals and project teams in Marketing, Operations, and Development.
• Oversight of characterization or feasibility testing as well as computer simulations.
• Use project planning and monitoring methods to ensure timely completion.
• Review and approve completed design documentation.

Qualifications

• Required: Master’s degree
• Required: Bachelor’s degree and 2 years of engineering experience
• Required: Associate’s degree and 6 years of engineering experience
• Required: High school diploma / GED and 8 years of engineering experience
• Preferred: 4+ years of progressive experience as an engineer or scientist within the appropriate field of study.
• Preferred: 2+ years of experience in product development working with mechanical medical devices, ideally combination products (device/biologics combination).
• Preferred: Formal Systems Engineering training/certification.
• Preferred: Demonstrated applied lean 6 Sigma competency.
• Preferred: Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.