Systems Engineer, Medical Devices — Drive Innovation & Impact

Mizuhosi; Union City (CA); Hybrid; USD 82.000 - 150.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision

401k with matching

Educational assistance

Zusammenfassung

Mizuho OSI in Northern California is seeking a Systems Engineer to join a small, agile team responsible for medical device development from concept through testing.

You will translate customer needs into requirements, integrate software-controlled electromechanical systems, and ensure design history files and plans are maintained. Senior roles may lead projects and mentor others. We offer a comprehensive benefits package and annual bonus.

Qualifikationen

• Bachelor's degree in engineering or related field and relevant experience.
• Strong analytical skills and ability to apply engineering principles.
• Solid understanding of systems engineering principles and methods.
• Ability to translate customer needs into design requirements and performance.

Aufgaben

• Create innovative solutions addressing user needs and differentiating products.
• Translate customer needs into requirements; document design inputs/outputs.
• Collaborate to determine best technologies for the product.
• Develop and maintain design history files and deliverables.
• Plan milestones, schedules and task lists; manage data and issues.
• Maintain knowledge of medical devices, regulations and quality systems (FDA 21 CFR 820).
• Perform risk management, mitigate and document actions.
• Execute engineering, verification, validation testing with protocols and reports.
• Develop processes and tools for testing and evaluation.
• Support design transfer to manufacturing and serviceability.
• Support sustaining activities including reliability and manufacturability improvements.

Kenntnisse

Analytical thinking

Systems engineering

Team collaboration

Problem solving

Ausbildung

Bachelor's degree in engineering or related field

Master's degree (preferred)

Tools

MATLAB

LabVIEW

EA (Engineering Applications)

Jobbeschreibung

Mizuho OSI in Northern California is seeking a Systems Engineer to join a small, agile team responsible for medical device development from concept through testing.

You will translate customer needs into requirements, integrate software-controlled electromechanical systems, and ensure design history files and plans are maintained. Senior roles may lead projects and mentor others. We offer a comprehensive benefits package and annual bonus.