Systems Engineer V

bioMérieux•Salt Lake City, UT

About The Position

This engineer works within a project team – generally in collaboration with a Project Manager. This engineer uses experience and education to perform the types of engineering activities which are generally considered within the realm of systems engineering, integrating electrical, mechanical, and firmware designs, and any other expertise that might be held by this particular individual. This engineer is expected to work and communicate well with other team members and leads to ensure instrument product development activities of the company are accomplished in accordance with bioMerieux’s quality system. Primary Duties General: uses experience and education to perform the types of engineering activities which are generally considered within the realm of systems engineering Description: Uses engineering concepts, company SOPs/WIDs, department SOPs/WIDs to solve a variety of complex engineering problems across functional groups and disciplines. Works on: projects of significant scope and complexity. Generally works with a team of engineers. Influence: works in collaboration with a Project Manager, provides technical leadership on a project, and provides oversight and guidance to project engineers. System Engineering: Acts as the technical lead on projects under the direction of the department director and Project Manager. Interfaces with engineers, designers, technicians, and specialists of multiple disciplines to ensure that system level design objectives are met and conform to requirements. Works with engineers to resolve technical issues associated with design and implementation of the system. Determines the overall technical direction and architecture for the project with management to ensure solution meets corporate / strategic vision for the project. Writes the Engineering Risk Analysis, product (and/or process) requirements, product (and/or process) verification, high‑level block diagram, and the verification plan with the Project Manager and in collaboration with other project leads. Attends project technical reviews. Reviews project documents for technical content. Attends risk analysis meetings, reviews FMEAs, and ensures risk mitigation and translation into specifications. Attends risk analysis meetings, reviews FMEAs, and ensures risk mitigation and translation into specifications. Evaluate subsystems and subassemblies against system requirements. Ensures proper subsystem and subassembly interfaces. Ensures compliance to standards and regulations (e.g. UL, CE, FDA, and ISO). Responsible for the technical aspects of the Design History File and the Device Master Record. May write the product (and/or process) level Design Change Notice and associated summary and Change Order supporting Instrument release. Supports the creation of the project Work Breakdown Structure in collaboration with the Project Manager. Assists the Project Manager with stakeholder identification. Makes design and technical decisions subject to review by the department Director, Project Manager, Manager, Principal, and other engineers. Implements mitigation to evaluated design risks and provides translation into design specifications. Reviews all technical aspects of the project and makes determinations regarding system risks. Perform all work in compliance with company quality procedures and standards. Perform other duties as assigned.

Requirements

Bachelor degree required – Engineering
10+ years of professional related experience with degree – Engineering experience
Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
Critical thinking, using logic and reason to analyze information and make decisions in the workplace.
Driving continuous improvement by evaluating processes and implementing necessary changes.
Technical skills with mastery level commensurate to the job level, marked by specialization and innovation in the field of work.
Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
Creativity in forming new ideas, solutions, and approaches to challenges; to think outside‑the‑box.
Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel — Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance.
Ability to remain in stationary position, either sitting or standing, for prolonged periods: Yes
Ability to adjust or move objects up to 50 pounds in all directions: Yes

Nice To Haves

Analog and digital circuit design
Solidworks
Compliancy (CE, UL, FCC, RoHS)
Machining (esp. CNC)
Optics, plastics design
Altium Designer

Responsibilities

Uses engineering concepts, company SOPs/WIDs, department SOPs/WIDs to solve a variety of complex engineering problems across functional groups and disciplines.
Acts as the technical lead on projects under the direction of the department director and Project Manager.
Interfaces with engineers, designers, technicians, and specialists of multiple disciplines to ensure that system level design objectives are met and conform to requirements.
Works with engineers to resolve technical issues associated with design and implementation of the system.
Determines the overall technical direction and architecture for the project with management to ensure solution meets corporate / strategic vision for the project.
Writes the Engineering Risk Analysis, product (and/or process) requirements, product (and/or process) verification, high‑level block diagram, and the verification plan with the Project Manager and in collaboration with other project leads.
Attends project technical reviews. Reviews project documents for technical content.
Attends risk analysis meetings, reviews FMEAs, and ensures risk mitigation and translation into specifications.
Evaluate subsystems and subassemblies against system requirements.
Ensures proper subsystem and subassembly interfaces.
Ensures compliance to standards and regulations (e.g. UL, CE, FDA, and ISO).
Responsible for the technical aspects of the Design History File and the Device Master Record.
May write the product (and/or process) level Design Change Notice and associated summary and Change Order supporting Instrument release.
Supports the creation of the project Work Breakdown Structure in collaboration with the Project Manager.
Assists the Project Manager with stakeholder identification.
Makes design and technical decisions subject to review by the department Director, Project Manager, Manager, Principal, and other engineers.
Implements mitigation to evaluated design risks and provides translation into design specifications.
Reviews all technical aspects of the project and makes determinations regarding system risks.
Perform all work in compliance with company quality procedures and standards.
Perform other duties as assigned.