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Systems Engineer

Company:
LanceSoft Inc.
Location:
Skaneateles Falls, New York, United States
Posted:
April 10, 2019

Description:

Job Summary:

Responsible for systems engineering as a member of a multidisciplinary new product development team. Understands and defines customer needs; product functionality and performance requirements; product architecture, constraints and trade-offs; design requirements; risk management, and technical risks of new products being developed as well as any changes to current products. Collaborates with other team members on the overall design of the final product. Determines what evidence is required to show compliance, including the amount of data required and the methodology for collecting and analyzing the data. Provide objective evidence that a product design meets its specified requirements and meets the identified user’s needs and intended uses.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

– Other duties may be assigned:

•Develop/maintain the product use-cases and needs based on knowledge of customers and their environments

•Apply requirement driven design through systems engr. principles, communication, and leadership skills

•Develop/maintain system architecture for the products, based on technology and platform strategies

•Define subassembly interfaces and allocate subassembly requirements to design teams

•Develop/maintain the risk management file in accordance with ISO 14971 and ensure product safety

•Conduct impact analysis for design changes and implement necessary actions

•Identifies technical problems and provides innovative and creative solutions

•Ensures requirements can be verified and validated

•Defines and develops required test fixtures in conjunction with test facilities and ensures they are validated.

•Collaborates with internal and external testing facilities to identify appropriate resources and gather verification and validation data

•Reviews, statistically analyzes, and documents pass/fail conclusions on gathered data

•Measures and reports on progress toward completion of verification and validation

•Supports root cause identification, corrective actions and re-verification/validation of identified product failures

•Generates verification and validation reports and traceability summaries to document the conclusions reached in compliance with FDA and other regulatory requirements

EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:

•BS Degree (Mechanical, Electrical, Software Engineering or comparable technical discipline)

•4+ years of engineering experience

•2+ years of experience working with translating customer needs into design requirements and architecture

•2+ years of experience applying risk management methodologies including DFMEA and Risk/Hazard Analysis

•Demonstrated experience working on new product development projects resulting in successful products in compliance with FDA or other regulatory bodies.

• Demonstrated experience making project tradeoff decisions due to constraints and drive action to decisions

•Strong organizational and communication skills

•Proficient problem solving skills

•Strong interpersonal skills with the ability to work collaboratively with others in a team environment

•Working knowledge of systems engineering methodologies

•Working knowledge of Microsoft Office and Engineering software

•Experience with DFSS tools such as Voice of the Customer, Critical to Quality, Quality Function Deployment.

•Thrives on change and adapts to leader initiated changes