bioMérieux · 18 hours ago
Systems Engineer V
Salt Lake City, UT
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expbioMérieux is a company focused on providing diagnostic solutions. They are seeking a Systems Engineer V to lead technical projects, integrate various engineering disciplines, and ensure compliance with quality standards and regulations.
Biotechnology
Responsibilities
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
Works in collaboration with a Project Manager, provides technical leadership on a project, and provides oversight and guidance to project engineers
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
Qualification
Required
Bachelor degree required – Engineering
10+ years of professional related experience with degree – Engineering experience
Preferred
Analog and digital circuit design
Solidworks
Compliancy (CE, UL, FCC, RoHS)
Machining (esp. CNC)
Optics, plastics design
Altium Designer
Company
bioMérieux
A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics.
10001+ employees
H1B Sponsorship
bioMérieux has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
2022 (1)
Funding
Current Stage
Late StageLeadership Team
Jana Inman
CFO Global R&D
Aaron Ford
Talent Acquisition Partner II
Recent News
MarketScreener
2024-04-11
MarketScreener
2024-04-10
MarketScreener
2024-03-27
Company data provided by crunchbase