Principal Engineer (Mechanical)

301055 Fenwal, Inc.; Warrendale (Allegheny County); On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) with company contribution

Wellness program

Job summary

301055 Fenwal, Inc. is seeking a Principal Engineer to manage the life-cycle of medical hardware products. This role involves mechanical engineering, addressing product quality issues, and maintaining design documentation.

The successful candidate will require a degree in engineering coupled with significant experience, with a salary range from $100,000 to $120,000 annually, depending on qualifications.

Qualifications

• 5+ years of relevant experience (or equivalent Master’s/Ph.D. with less experience).
• Solid understanding of mechanical engineering principles.
• Ability to operate in cross-functional teams.

Responsibilities

• Lead creation of hardware requirements and design specifications.
• Resolve manufacturing product quality issues.
• Analyze material specifications for proper functionality.

Skills

3D modeling

FEA

FMEA

tolerance analysis

critical thinking

Education

B.S. degree in Engineering

M.S. in Engineering

Ph.D. in Engineering

Job description

Job Summary: The Principal Engineer performs Mechanical Engineering tasks for the life‑cycle management of 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. The role also involves performing technical and problem‑solving activities, in collaboration with Quality Assurance, to analyze and resolve field and manufacturing product issues.

Salary Range: $100,000 to $120,000 Per Year dependent on education and experience.

Immigration Notice: 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 when your current work authorization expires. We ask that candidates answer all work authorization questions fully and accurately during the application process.

Responsibilities

1. Supports / leads the creation of hardware requirements and design specifications, including 3D modeling, FEA, FMEA, tolerance analysis, and drawing creation.
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. Network with senior internal and external personnel in areas of expertise.
6. Routinely provide advice and assist 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 M.S. 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 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.

Benefits and Compensation

• Competitive salary ranging from $100,000 to $120,000 per year.
• Comprehensive benefits package including medical, dental, and vision coverage, life insurance, disability, 401(k) with company contribution, and a wellness program.

Employment At‑Will: Joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and the employer have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Equal Opportunity/Affirmative Action: 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.