ICU Medical · 2 weeks ago
Senior Engineer, Manufacturing
ICU Medical is a global market leader in IV therapy and critical care products. The Senior Engineer, Manufacturing will drive process improvements and manage complex engineering projects while adhering to established design control processes and good engineering practices.
Health CareMedical Device
Responsibilities
Initiate and manage projects with adherence to program-management guidelines
Own and manage CAPA tasks and deliverables (Corrective and Preventive)
Lead vendor assessment and review of materials/machine technical information
Identify and implement process and product modifications to improve manufacturability and impact on automation equipment
Consult with Product and Molding Engineers on in-process non-conformances
Process technical expert for multiple manufacturing production lines
Create and edit documents to support Production
Work with Quality Engineers on qualification activities for new or modified processes and equipment
Receives general project direction. Responsible for project progress
Analyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions. Plans, organizes and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements
Work on special projects as they arise
Decisions consistently affect multiple or critical projects in the business and may impact external relationships
Delivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus
Spearhead initiatives for continuous process improvements
Develop a broad understanding from start to end of the product manufacturing process in the company
Perform design assessments, active participation in design reviews and risk management processes
Network with senior internal and external personnel
Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager
Qualification
Required
Must be at least 18 years of age
Bachelor's degree from an accredited college or university (Engineering or Technology)
7+ years of experience
Substantial knowledge in one or more key process areas: automation, medical-device assembly, controls, etc
Understanding of strength of materials, plastic injection molding, fixturing, testing, and process control techniques
Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.)
Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
Solid works knowledge to interpret part dimensions, sectional views, conduct mates and build assemblies
Technical writing competency
Has mastered best practices. Has an advanced understanding of engineering discipline
Can assess what work supports the product strategy and make insightful recommendations regarding priorities
Expert in your domain of expertise. Familiar in other areas of domain expertise within the team
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
H1B Sponsorship
ICU Medical 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
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Company data provided by crunchbase