Hill-Rom System Engineer II in Chicago, Illinois
This position is responsible for coordination and management of technical system design aspects 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. This role will also interface 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES: – Other duties may be assigned:
Work with Program Management and Upstream Marketing to plan new development and product change activities required to achieve program goals.
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 and workflows.
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 incorporated 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 product configurations are created and updated as necessary to meet the market needs.
Member of cross functional support team. Specific duties are as follows:
Manages periodic product support 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.
Resource for Field Action Determinations.
Assists with explaining project information or processes in a regulatory or supplier audit.
Performs other duties as requested
EDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
Bachelor’s Degree in Engineering or related field and 2 years of experience.
Must possess experience writing specifications and participating in a product development process in a regulated environment.
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. Correctly prioritizes their own work and effectively manages ambiguity and changing priorities.
Must be flexible and adaptable.
Possess the ability to manage time and prioritize critical priorities.
Must demonstrate the ability to increase knowledge.
Job: Research & Development
Primary Location: United States-Wisconsin-Milwaukee
Other Locations: United States-Illinois-Chicago, IL, United States-Wisconsin-Madison
Posting Entity Mortara
Req ID: 21123344