Principal Systems Engineer

* Prefer local DC/MD/VA Candidates - if outside of those areas, MUST be willing to travel to HQ-Germantown, MD once a month for a couple of days.

The Principal Systems Engineer is responsible for medical device development projects including working with a cross-functional team on tasks such as: project planning, defining requirements, traceability assurance, testing, problem debugging, risk management, and schedule compliance. Position will lead varied stakeholders, modeling performance aspects of the system and defining various interfaces between sub-systems and environments. The Principal Systems Engineer is multidisciplinary but possesses a depth of knowledge in multiple focused engineering areas.

• Leads development of systems engineering project plans; provides feedback on development strategy, development cost, product cost, project risks (technical, schedule or deliverable), and timelines for each project
• Leads systems engineering activities such as architecting, planning, analyzing, design, integration and test.
• Prepare technical reports including System Design, Design of Experiments (DOE), external interfaces, internal interfaces, component qualification, product testing, FMEA, statistical analysis
• Coordinates and is accountable for Human Factors activities and deliverables
• Leads the engineering teams in all phases of development across multiple projects; investigate interchangeability, replacement, cost factors, and ease of manufacture.
• Accountable for the execution of the Product Development Process with the project team to create and release Product Requirements, Design Specifications and Design Descriptions for assigned designs, applicable standards, and procedures. Work with all Project team members throughout the development to ensure that products are produced in a safe, efficacious and quality manner while keeping within established time frames.
• Communicate project information both within and external to the company

• Candidate must have strong analytical skills to analyze dependencies in a project, and be able to proactively understand/anticipate the critical paths on projects
• Ability to lead engineering projects and work autonomously
• Experienced in leading a cross-functional engineering team
• Experienced with product development processes in a highly regulated industry
• Applies and champions Systems Engineering best practices; owns applicable Standard Operating Procedures
• Experienced with common engineering tools
• BS degree is required, and graduate degree (MS or PhD) is preferred (EE, BME, CS, CE)
• 8+ years’ experience in design/development of multi-domain systems; particularly desirable is medical device development experience with BS, or 6+ years’ experience with MS/PhD