Principal Engineer (Sustaining Hardware)

Fresenius Kabi USA•Warrendale, IL

2d•$100,000 - $115,000•Hybrid

About The Position

The Principal Engineer (Sustaining Hardware) will perform sustaining engineering activities and technical project management related to commercial infusion pump products for the Ivenix Infusion System portfolio with minimal supervision. Apply specialized knowledge to manage and complete complex projects, including design and/or process related activities. Develop strategies where clear guidelines do not exist and creative thinking is required. Generate and implement innovative solutions to mid to highly complex problems. Lead activities to meet business goals by driving quality improvements, addressing material obsolescence, meeting delivery requirements, and implementing cost reductions / product enhancements. Requires working in a team environment with cross-functional team members, such as manufacturing sites, marketing, quality, regulatory, and other R&D departments. The position reports to the Director, Program Management. May provide guidance and leadership to junior engineers and manufacturing plant technical staff.

Requirements

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

Responsibilities

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