USA Systems Engineer II
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Job Location:
Milwaukee, WI - USA
Monthly Salary:
Not Disclosed
Posted on:
1 hour ago
Vacancies:
1 Vacancy
Job Summary
Description:
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 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:
Accountable for the entire product development process - from engaging with customers and marketing to compose and develop user needs to the eventual product launch:
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 development team.
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.
Plays a critical role in product development making sure the product meets all the functional and performance requirements and ensuring the manufacturing and service requirements are translated into product design.
Lead the development and documentation of the product systems architecture and systems level design including the decomposition of the system architecture and requirements into subsystem and interface specifications.
Provide technical leadership to the development team to ensure that the project successfully meets cost quality and schedule targets throughout the product life cycle.
Resolve competing constraints between interrelated functions (engineering manufacturing regulatory marketing etc.) required to deliver the product to market.
Plan and carry out system integration tasks to reduce problems in systems verification and validation.
Document traceability from requirements to verification activities and from requirements to design entities.
Resolve systems-related technical issues by applying problem solving tools such as cause and effect diagrams Pareto charts etc.
As lead integrator for the product proactively look out for integration issues during development tests and ensure module/system development is successful.
Adheres to Baxter Quality Management system & supports the quality audits.
Ensure end product configurations (MIS-14s etc.) are created and updated as necessary to meet the market needs.
Performs other duties as requested.
Essential competencies:
Bachelors degree in Electrical Mechanical Software Biomedical Engineering or related field and/or equivalent experience.
3 years of relevant experience.
A demonstrated track record in system development covering requirements management risk management cybersecurity usability performance and reliability.
Experience in using tools/practices like QFD Pugh Matrix CTQ DFR DFX.
Systems development experience in diagnostic cardiology medical devices or any other medical device is a definite plus.
Agile product development experience preferred.
Excellent communication inter-personal and leadership skills
Firm decision maker and shall possess good influencing skills
Openness to collaborate in interest of project/organization.
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.
Baxter BR: BR
Supplier Spotlight call scheduled for Thurs 5/14 at 11:30am CST. Please do not submit your candidates until after the call. If you could also join 5 minutes prior to the call I would appreciate it. Thank you for your support!
Microsoft Teams meeting
Join:
Meeting ID:
Passcode: Ef9pu3fT
Need help System reference
Dial in by phone
1 # United States Waukegan
Find a local number
Phone conference ID:#
Join on a video conferencing device
Tenant key: *************
Video ID:
Position Responsibilities:
Accountable for the entire product development process - from engaging with customers and marketing to compose and develop user needs to the eventual product launch:
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 development team.
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.
Plays a critical role in product development making sure the product meets all the functional and performance requirements and ensuring the manufacturing and service requirements are translated into product design.
Lead the development and documentation of the product systems architecture and systems level design including the decomposition of the system architecture and requirements into subsystem and interface specifications.
Provide technical leadership to the development team to ensure that the project successfully meets cost quality and schedule targets throughout the product life cycle.
Resolve competing constraints between interrelated functions (engineering manufacturing regulatory marketing etc.) required to deliver the product to market.
Plan and carry out system integration tasks to reduce problems in systems verification and validation.
Document traceability from requirements to verification activities and from requirements to design entities.
Resolve systems-related technical issues by applying problem solving tools such as cause and effect diagrams Pareto charts etc.
As lead integrator for the product proactively look out for integration issues during development tests and ensure module/system development is successful.
Adheres to Baxter Quality Management system & supports the quality audits.
Ensure end product configurations (MIS-14s etc.) are created and updated as necessary to meet the market needs.
Performs other duties as requested.
Essential competencies:
Bachelors degree in Electrical Mechanical Software Biomedical Engineering or related field and/or equivalent experience.
3 years of relevant experience.
A demonstrated track record in system development covering requirements management risk management cybersecurity usability performance and reliability.
Experience in using tools/practices like QFD Pugh Matrix CTQ DFR DFX.
Systems development experience in diagnostic cardiology medical devices or any other medical device is a definite plus.
Agile product development experience preferred.
Excellent communication inter-personal and leadership skills
Firm decision maker and shall possess good influencing skills
Openness to collaborate in interest of project/organization.
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.
Baxter BR: BR
Supplier Spotlight call scheduled for Thurs 5/14 at 11:30am CST. Please do not submit your candidates until after the call. If you could also join 5 minutes prior to the call I would appreciate it. Thank you for your support!
Microsoft Teams meeting
Join:
Meeting ID:
Passcode: Ef9pu3fT
Need help System reference
Dial in by phone
1 # United States Waukegan
Find a local number
Phone conference ID:#
Join on a video conferencing device
Tenant key: *************
Video ID:
Additional Details
- Shore Options Available for this Position : Onshore Only
- Direct or Indirect : Indirect
- Time clock worker : No
- Shift : USA-1
