Systems Engineer, Medical Device

Responsibilities

• Create innovative solutions to address user needs in products that differentiate the company in the market.
• Translate customer needs into requirements and engineering specifications.
• Document design input & output.
• Meld technical contributors into a unified team and collaborate to determine best technologies for the product.
• Develop, manage and maintain design history files and related deliverables.
• Develop, maintain and execute to plans, milestones, schedules and task lists.
• Manage and logically organize data to identify and describe problems and assess the suitability and quality of technical solutions.
• Perform complaint, failure and risk management activities, develop mitigation and risk control strategies and generate supporting documentation.
• Perform engineering, integration, verification and validation testing, including protocol development, report generation and regression analysis.
• Develop and document processes, methods and tools for product testing and evaluation.
• Support cross-functional Design Transfer process to ensure product designs manufacturable & serviceable.
• Support product sustaining activities including value engineering, reliability improvements, manufacturability improvements, field issues with technical and impact analysis.
• Manage, prioritize and align work activities with project schedules.
• Understand, follow and support Mizuho OSI’s internal Quality System policies, procedures and work instructions including but not limited to applicable external regulations (21 Code of Federal Regulations Part 820 Quality System Regulations and applicable International Standards).

Qualifications & Requirements

• Bachelor's Degree in Engineering or related field 1-8 YOE, Master’s degree 1-3 YOE, PhD 1+ years of experience.
• Strong analytical skills and ability to apply engineering principles using logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to comprehend an extensive variety of technical instructions in mathematical and/or diagrammatic form and translate that into design requirement and/or performance.
• Solid understanding of systems engineering principles and methods, system modeling and transformation applications.
• Ability to make and communicate decisions in a timely fashion; to formulate and execute a course of action.
• Ability to independently manage and prioritize work based on goals and objectives and provide deliverables in alignment with timelines and deadlines.
• Ability to adjust to changing timelines and priorities in a fast paced environment.
• Ability to collaborate cross-functionally and cross-organizationally and respond to the needs of internal customers.
• Strong interpersonal and communication skills and ability to effectively work in a team.
• Excellent written & verbal English communication skills and strong presentation skills.
• Adept use of Office Applications like MS Outlook, Excel, Word, PowerPoint, Visio and Project.

Benefits

Salary scale $82,000- $150,000 DOE + potential annual bonus + comprehensive benefits package.