Principal Engineer

Fresenius Kabi USA•Warrendale, PA

1d•$100,000 - $120,000

About The Position

The Principal Engineer performs Mechanical Engineering tasks for the life-cycle management for on-market products manufactured at the production unit of active and non-active hardware medical devices, software, and laboratory equipment. This includes maintaining design requirements, design specifications, and risk management documentation; performing mechanical testing; supporting verification and validation activities. This also includes performing technical and problem-solving activities, in collaboration with Quality Assurance, to analyze and resolve field and manufacturing product issues. Requires working in a team environment with cross-functional team members, such as manufacturing, quality, regulatory, and other R&D departments. This job position within the MedTech division of Fresenius Kabi USA hereby commits itself to protect any persons working under its control from work related hazards to health and safety as well as to protect the environment as the basis of life. This includes the prevention of diseases, incidents, and pollution as well as the responsible and sustainable use of resources. Our aim is to enhance our performance in the area of occupational and environmental safety, and to fulfill compliance obligations. To achieve this target, we implement and continuously improve the integrated management system according to ISO 14001 (Environmental Management System, or EMS) and ISO 45001 (Occupational Health and Safety Management Systems, or OHSMS).

Requirements

B.S. degree in Engineering and 5+ years of relevant experience, or Masters and 2+ years related experience, or Ph.D. and 1-2 years’ experience.
Displays a solid understanding of theories/practices utilized by mechanical engineers, e.g. 3D modeling, FEA, tolerance analysis, etc., and from other disciplines outside the primary area of expertise.
Strong critical thinking skills and the ability to function in a sometimes-ambiguous situations.
Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
Effectively operate in and may facilitate cross-functional teams with guidance.

Responsibilities

Supports / leads the creation of hardware requirements and designs specifications, including 3D modeling, FEA, FMEA, tolerance analysis, and drawing creations.
Utilize engineering principles, technical analysis, and problem-solving tools to resolve field and manufacturing product quality issues.
Independently define and analyze material specifications, components, and process techniques to ensure proper functionality and long-term performance.
Develop and execute protocols for evaluating existing mechanical designs.
Networks with senior internal and external personnel in areas of expertise.
Routinely provides advice and assists team members regarding unique problems.
Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
Performs other related duties as assigned.