Senior Engineer, Product

ICU Medical•Salt Lake City, UT

About The Position

The Sr. Engineer, Product is responsible for owning and driving product improvements through adherence to established design control processes, good engineering and documentation practices. They are considered a specialist on complex technical and business matters, may assume a team lead role for work in the group and be highly independent in accomplishing work. The key responsibility of this position is to completes advanced engineering projects with peer input and guidance from engineering management, exercising judgement and taking action while adhering to defined procedures during project support & improvements. Essential Duties & Responsibilities Immediate expectations Receives general project direction. Responsible for project progress. Analyze, plan, organize and complete projects of a very complex nature. Develops scope and provide creative solutions. Plans, organizes and conduct 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. Initiate and manage projects with adherence to program management guidelines Perform Design assessments, active participation in Design reviews, Risk Management processes. Own and manage CAPA tasks and deliverables (Corrective and Preventive) Coordinate efforts with the Materials Group to assess vendors and provide materials technical information Represent Product Engineering to identify possible product modifications to improve manufacturability and impact on automation equipment Maintain Product specifications; consult with manufacturing on product non-conformance. 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 Long term expectations Spearhead initiatives for continuous process and product improvements (assess tolerance stack up of sustaining designs to increase robustness) Develop a broad understanding from start to end of the product manufacturing process in the company Network with senior internal and external personnel Intellectual Property review and assessment 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.

Requirements

Must be at least 18 years of age
Bachelor’s degree from an accredited college or university (Engineering or Technology)
7+ years’ experience
Understanding of strength of materials, automation, plastic injection molding, part assembly, fixturing, testing, and process control techniques
Solid works to interpret part dimensions, sectional views, conduct mates & build assemblies. Able to run basic simulations.
Risk Management, FMEA generation and Risk Analysis
Six-Sigma Methodology (DOE, Process Capability, Gage R&R, etc.) - use of Minitab Software for analysis
Knowledge of the Medical Device Industry and familiarity with FDA QSR regulations
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.

Responsibilities

Analyze, plan, organize and complete projects of a very complex nature
Develops scope and provide creative solutions
Plans, organizes and conduct 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
Initiate and manage projects with adherence to program management guidelines
Perform Design assessments, active participation in Design reviews, Risk Management processes
Own and manage CAPA tasks and deliverables (Corrective and Preventive)
Coordinate efforts with the Materials Group to assess vendors and provide materials technical information
Represent Product Engineering to identify possible product modifications to improve manufacturability and impact on automation equipment
Maintain Product specifications; consult with manufacturing on product non-conformance
Work on special projects as they arise
Spearhead initiatives for continuous process and product improvements (assess tolerance stack up of sustaining designs to increase robustness)
Develop a broad understanding from start to end of the product manufacturing process in the company
Network with senior internal and external personnel
Intellectual Property review and assessment
Manages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures