Qualifications:
Bachelor's Degree in Engineering (Mechanical/Electrical/Industrial/Computer Sci) along with 4 yrs of experience
Medical Device or Equipment experience. Defense or Aerospace industries also acceptable
MatLab, LabView, Jama or EA. Office Applications like MS Outlook, Excel, Word, PowerPoint, Visio and Project.
Strong Product Development Systems Engineering experience, at least one full cycle of product development
Experience in Test and V&V
Ability to comprehend an extensive variety of technical instructions in mathematical and/or diagrammatic form and translate that into design requirement and/or performance.
Ability to find creative or innovative solutions for design of products.
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.
Responsibilities:
Translate customer needs into requirements and engineering specifications.
Develop, manage and maintain design history files and related deliverables.
Develop, maintain and execute to plans, milestones, schedules and task lists.
Manage data to identify and describe problems and assess the suitability and quality of technical solutions.
Maintain up-to-date knowledge of medical devices, technologies and regulatory landscape relate to the companyâ s products.
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.