Systems Engineer

Stefanini Group•Milwaukee, WI

2d•Onsite

About The Position

Stefanini Group is hiring a Systems Engineer in Milwaukee, WI. This role is responsible for the coordination and management of system design for one or more groups of related products (Programs) to achieve defined program goals. This includes maintenance and engineering support of existing products. The Systems Engineer will interface with various departments such as Marketing, Sales, Service, Operations, Quality Assurance, and Regulatory Affairs to define product requirements, communicate information, and address product-related issues.

Requirements

Bachelor's degree in Electrical, Mechanical, Software, Biomedical Engineering or related field and/or equivalent experience.
3+ years of relevant experience.
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.
Excellent communication, interpersonal and leadership skills.
Firm decision maker with good influencing skills.
Openness to collaborate in the interest of project/organization.
Strong organizational skills.
Fluent in English (both oral and written) with excellent oral and written communication skills.
Ability to work independently, be self-motivated, and complete tasks with minimal supervision.
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.
Team player with outstanding customer service skills and self-motivation.
Good listening skills and ability to easily learn new skills and concepts.
Ability to manage time and prioritize work.
Flexible and adaptable.
Ability to manage time and prioritize critical priorities.
Demonstrates the ability to increase knowledge.

Nice To Haves

Systems development experience in diagnostic cardiology medical devices or any other medical device is a definite plus.
Agile product development experience preferred.

Responsibilities

Accountable for the entire product development process, from customer engagement and marketing to user needs composition and 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.
Understand and translate market needs into technical product requirements with Upstream Marketing.
Ensure technical product requirements are communicated and understood by the development team as a leader of the technical team.
Own the Design History File (DHF) and ensure technical product requirements are clearly and thoroughly documented.
Create system-level specifications.
Ensure usability requirements are adequately addressed per IEC 62366.
Lead technical resources for Risk Management per IEC 14971.
Coordinate and review design-level requirements to ensure they meet system requirements and market needs.
Coordinate and review system and design-level requirements to ensure they adequately consider serviceability and manufacturability.
Responsible for DHF traceability by ensuring all requirements have been verified and validated.
Create Verification and Validation Plans to scope testing and maintain traceability.
Complete all documentation required for compliance to standards.
Ensure requirements shared by similar products and their implementations are harmonized across those products.
Work with technical writing to ensure user documentation is sufficient.
Ensure the product meets all functional and performance requirements, and that manufacturing and service requirements are translated into product design.
Lead the development and documentation of product systems architecture and systems-level design, including decomposition into subsystem and interface specifications.
Provide technical leadership to ensure the project meets cost, quality, and schedule targets throughout the product life cycle.
Resolve competing constraints between interrelated functions (engineering, manufacturing, regulatory, marketing, etc.).
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 system-related technical issues using problem-solving tools.
Proactively identify integration issues during development tests and ensure module/system development is successful.
Adhere to the client's Quality Management system and support quality audits.
Ensure end product configurations (MIS-14s, etc.) are created and updated as necessary.
Performs other duties as requested.