Please note: This position cannot provide employment-based immigration sponsorship now or in the future. Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires. We ask that candidates answer all work authorization questions fully and accurately during the application process.
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.Responsibilities
1. Supports / leads the creation of hardware requirements and designs specifications, including 3D modeling, FEA, FMEA, tolerance analysis, and drawing creations.
2. Utilize engineering principles, technical analysis, and problem-solving tools to resolve field and manufacturing product quality issues.
3. Independently define and analyze material specifications, components, and process techniques to ensure proper functionality and long-term performance.
4. Develop and execute protocols for evaluating existing mechanical designs.
5. Networks with senior internal and external personnel in areas of expertise.
6. Routinely provides advice and assists team members regarding unique problems.
7. Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
8. Performs other related duties as assigned.
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.
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).
Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
Top Skills
What We Do
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.
Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.
Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.
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