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Fresenius Kabi USA · 6 days ago

Principal Engineer (Sustaining Hardware)

Lake Zurich, IL

Full-time

Hybrid

Senior Level, Lead/Staff

$100K/yr - $115K/yr

5+ years exp

Fresenius Kabi USA is seeking a Principal Engineer (Sustaining Hardware) to perform sustaining engineering activities and technical project management for their Ivenix Infusion System portfolio. The role involves managing complex projects, driving quality improvements, and collaborating with cross-functional teams to enhance product performance and address engineering challenges.

Health Care

No H1B

Responsibilities

This Engineer schedules and leads a project team through the planning and execution of a smaller project or defined piece of a larger project; includes constructing detailed and accurate project schedules, preparing resource / expense estimates, interfacing with development / manufacturing / procedures / support groups for project execution

Displays a solid understanding of engineering principles to resolve difficult problems, from conception to final design with team input

Provide subject matter expertise in the areas of mechanical engineering related to electro-mechanical and devices and associated manufacturing processes. Serve as Technical Approver for product design and/or manufacturing process changes related to infusion pump commercial products

Plans, schedules, and leads project assignments in the evaluation, selection, and adoption of various engineering techniques, procedures, and criteria with minimal to no guidance

Maintains the overall project schedule and budget

Collaborate with cross functional groups to complete Change Control documentation to support the execution of the project

Identifies solutions to complex problems through adoptions and modifications of standard technical processes

Coordinates engineers / technicians / manufacturing plant personnel on assigned work

Advise management on proposals and courses of action using both written and verbal methods

Effectively operates in and facilitates cross-functional teams with minimal guidance

Provide solutions and recommendations that reflect understanding of business objectives and cost implications

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Qualification

Mechanical EngineeringElectro-mechanical DevicesProject ManagementRegulatory GuidelinesMS ProjectAnalytical SkillsProblem SolvingWritten CommunicationVerbal CommunicationTeam Collaboration

Required

Bachelor's degree in Mechanical Engineering (or related Engineering degree) and 5+ years related experience in design and support of complex electro-mechanical devices, preferably in FDA regulated medical device industry

Demonstrated project management skills with ability to manage / prioritize multiple concurrent projects

Experience with theories and practices utilized by other disciplines outside of primary area of expertise

Ability to work as a collaborative team member

Excellent attention to detail and working knowledge of applicable regulatory guidelines and standards

Strong problem solving and analytical skills

Excellent written and verbal communication skills

Experience with MS Project or similar project scheduling tool