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Systems Engineer

Are you the next best Systems Engineer? If so, we?re looking for you!

Our client is actively seeking a talented Systems Engineer to work at their location in Skaneateles Falls, NY. This is a twelve month contract.

Job Overview:

Responsible for coordination and management of system design for one or more groups of related products (i.e. ?Programs?) to achieve defined program goals. This includes work related to the development of new products, and maintenance and engineering support of existing products. Interfaces with other departments including Marketing, Sales, Service, Operations, Quality Assurance and Regulatory Affairs to define product requirements, communicate important information, and address issues relative to each product.

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.?

Work environment:

The work setting is an office environment which has minimal noise level.

Key Responsibilities:

  • Work with Engineering Project Management to define and scope projects to achieve program goals.
  • Participate as a member of project teams for the assigned program.
  • Work with Upstream Marketing to understand and translate market needs into technical product requirements.
  • As a leader of the technical team, ensure technical product requirements are communicated and understood by the technical staff.
  • Owner of the Design History File (DHF).
  • Responsible for ensuring technical product requirements are clearly and thoroughly documented.

This includes the following:

  • Creation of system level specifications.
  • Ensures usability requirements are adequately addressed per IEC 62366.
  • Lead technical resource for Risk Management per IEC 14971.
  • Coordination and review of design level requirements to ensure they meet the system requirements and market needs.
  • Coordination and review of system and design level requirements to ensure they adequately consider serviceability and manufacturability of the product.
  • Responsible for DHF traceability by ensuring all requirements have been verified and validated. This includes creation of Verification and Validation Plans to scope the extent of testing required to maintain adequate traceability is maintained during a development project. This also includes completion of all documentation required to ensure compliance to standards.
  • Ensures requirements shared by similar products and their implementations are harmonized across those products, where possible.?
  • Work with technical writing to ensure user documentation is sufficient.
  • Ensure end product configurations (MIS-14s, etc.) are created and updated as necessary to meet the market needs.
  • Leader of the Program Support Team.?
  • 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

Specific duties are as follows:

  • Manages periodic Program Support Team meetings.
  • Primary point of contact for Technical Support escalations.
  • Assist with complaint investigations as needed.
  • Participate in CAPA activities as needed.
  • Management of Post Market Record investigations.
  • Resource for Post Market risk assessments.
  • Management of Field Action Determinations.
  • Assists with explaining project information or processes in a regulatory or supplier audit.
  • Performs other duties as requested.

Requirements:

  • 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.
    • Bachelor?s Degree in Engineering or related field and/or equivalent experience and 2+ years of experience.
    • Must have strong organizational skills.
    • Must be fluent in English (both oral and written) with excellent oral and written communication skills.
    • Works independently, is self-motivated and able to complete tasks with minimal supervision.
    • Must have the ability to initiate and develop creative solutions.
    • Acts with a sense of urgency, illustrates ambition and drives for completion of tasks/projects.
    • Strong proficiency in Office applications skills.
    • Must be a team player, possess outstanding customer service skills and be self-motivated.
    • Possess good listening skills, and easily learn new skills and concepts.
    • Ability to manage time and prioritize work.
    • Must be flexible and adaptable.
    • Possess the ability to manage time and prioritize critical priorities.
    • Must demonstrate the ability to increase knowledge.
  • 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

Job Requisition # 28618

APC believes that the workplace should be fun and enjoyable. Join our team today and ignite your career!

Meet APC

Company ? Staffing ? 501 ? 1000 employees

APC is a professional services organization focused on engaging people and positively impacting lives. We offer excellent benefits and the opportunity for longevity, working with our premier fortune 100 clients. As professionals serving professionals, we take pride in providing our employees with the highest level of customer service and support, creating meaningful, fulfilling and rewarding experiences every day.

APC is committed to creating a diverse work environment and is proud to be an equal opportunity employer.? All qualified individuals will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, genetics, or veteran status.


 

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