Fresenius Kabi USA · 8 hours ago
Principal Engineer (Sustaining Hardware)
Warrendale, PA
Full-time
Hybrid
Senior Level, Lead/Staff
$100K/yr - $115K/yr
5+ years expFresenius Kabi USA is seeking a Principal Engineer (Sustaining Hardware) to perform sustaining engineering activities and technical project management for commercial infusion pump products. The role involves leading project teams, providing subject matter expertise in mechanical engineering, and collaborating with cross-functional teams to drive quality improvements and cost reductions.
Health Care
No H1B
Hiring Manager
Carolyn Robles
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
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
Benefits
Position is eligible to participate in a bonus plan with a target of 8% of the base salary (include only if applicable to the grade level)
401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Health benefits to include medical, prescription drug, dental and vision coverage
Life insurance
Disability
Wellness program
Company
Fresenius Kabi USA
Fresenius Kabi is health care company specializing in medical and medical technologies.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Alex Garini
Chief Financial Officer
Sanjida Chowdhury
Vice President and Chief Compliance Officer, Region US
Recent News
Business Standard India
2025-10-23
Research and Markets
2025-08-05
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