Systems Engineer II
Posted on: August 6, 2022
What's Next? This is a great job! Kelly Engineering is seeking
talented Systems Engineer II
Job Title: Systems Engineer IIShift: M-F 8AM - 5PMLocation -
Milwaukee, WI Duration :12 Month Description/Comment: Position
- 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.
- Position 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
- 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
- Owner of the Design History File (DHF). Responsible for
ensuring technical product requirements are clearly and thoroughly
documented. This includes the following:
- o Creation of system level specifications. o Ensures usability
requirements are adequately addressed per IEC 62366.
- o Lead technical resource for Risk Management per IEC
- o Coordination and review of design level requirements to
ensure they meet the system requirements and market needs.
- o Coordination and review of system and design level
requirements to ensure they adequately consider serviceability and
manufacturability of the product.
- o 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
- This also includes completion of all documentation required to
ensure compliance to standards.
- o Ensures requirements shared by similar products and their
implementations are harmonized across those products, where
- Work with technical writing to ensure user documentation is
- Ensure end product configurations (MIS-14s, etc.) are created
and updated as necessary to meet the market needs.
- Leader of the Program Support Team. Specific duties are as
follows: o Manages periodic Program Support Team meetings.
- Primary point of contact for Technical Support
- 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. Essential
- Bachelors 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
- 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
- Ability to manage time and prioritize work.
- Must be flexible and adaptable.
- Possess the ability to manage time and prioritize critical
- Must demonstrate the ability to increase knowledge.
- Physical demands and work environment: Physical Demands: While
performing the duties of this job the employee will be sitting for
extended periods, will need to use a
computer/mouse/keyboard/monitor and will communicate and listen
both in-person and over the phone. Work environment: The work
setting is an office environment which has minimal noise level.us
Keywords: Kelly, Milwaukee , Systems Engineer II, Other , Milwaukee, Wisconsin
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