Systems Engineer II
Senseonics, Incorporated, Germantown, MD, United States
Job Summary
As a member of the Systems Engineering function, you will assist in developing medical devices by working with cross‑functional teams on tasks such as defining requirements, system design, traceability assurance, system testing, root cause investigations, design issue resolution, and schedule compliance. You will help produce deliverables that meet the quality system requirements and collaborate with various engineering functions and stakeholders to model system performance and define interfaces between subsystems and environments. Additional duties will be assigned by the Director, Systems Engineering or their 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 the 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.
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As a member of the Systems Engineering function, you will assist in developing medical devices by working with cross‑functional teams on tasks such as defining requirements, system design, traceability assurance, system testing, root cause investigations, design issue resolution, and schedule compliance. You will help produce deliverables that meet the quality system requirements and collaborate with various engineering functions and stakeholders to model system performance and define interfaces between subsystems and environments. Additional duties will be assigned by the Director, Systems Engineering or their 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 the 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.
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