Systems Engineer

Job Summary:

Your duties in the Systems Engineer II position will be to assist the Systems Engineering function in medical device development projects including working with cross-functional teams on such tasks such as: defining requirements, system design, traceability assurance, system testing, root cause investigations, design issue resolution and schedule compliance. The position will work with various engineering functions to produce deliverables that meet the requirements of the Quality System. The position will also work with varied stakeholders modeling performance aspects of the system and defining various interfaces between sub-systems and environments, as well as other duties as determined by the Director, Systems Engineering or his designee.

Duties and Responsibilities include, but are not limited to:

• Capture requirements, risk assessments, and failure analysis activities into medical quality system reports.
• Prepare technical reports including Verification and Validation, external interfaces, component qualification, product testing, FMEA and statistical analysis
• Participate in all phases of development across multiple projects; investigate interchangeability, replacement, cost factors and ease of manufacture. Coordinate with project team to create and release Product Requirements, Design Specifications and Design Descriptions for assigned designs applicable standards and procedures.
• Communicate project information to management clearly and accurately

Knowledge, Skills, Abilities and Requirements:

• Candidate must have expertise for medical device engineering activities
• BS or MS in Engineering (EE, BME) or equivalent.
• 3+ years’ experience in design/development of multi-domain systems; particularly desirable is medical device development experience