Principal Engineer (Mechanical)

Fresenius Kabi USA; Warrendale (Allegheny County); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Life insurance

Wellness program

Job summary

Fresenius Kabi USA in Warrendale is seeking a Principal Engineer to manage life-cycle for hardware medical devices and related equipment, leading mechanical design and verification activities. You will collaborate with QA, regulatory, manufacturing, and R&D to resolve field and manufacturing issues, ensure safety and compliance, and drive design improvements.

Strong background in 3D modeling, FEA, tolerance analysis and documentation is required; English proficiency essential for a regulated

Qualifications

• Bachelor's degree in engineering or higher with relevant experience.
• Experience with 3D modeling, FEA, tolerance analysis and drafting.
• Ability to work in cross-functional teams in a regulated environment.

Responsibilities

• Supports/leads hardware requirements and design specs, incl. 3D modeling, FEA, tolerance analysis.
• Resolve field and manufacturing product quality issues using engineering principles.
• Define material specs and process techniques to ensure functionality.
• Develop and execute protocols to evaluate existing mechanical designs.
• Collaborate with senior internal and external personnel.
• Provide guidance to team on complex problems.
• Innovate approaches to complex problems.
• Performs other related duties as assigned.

Skills

3D modeling

FEA

Tolerance analysis

Drawing creation

Mechanical design

Cross-functional collaboration

Problem-solving

Education

B.S. in Engineering

M.S. in Engineering

Ph.D.

Job description

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.

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.

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.

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.
• The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information

Salary Range: $100,000 to $120,000

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

We 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.