Principal Engineer (Product Sustaining)

Reposted 9 Days Ago
2 Locations
In-Office or Remote
100K-115K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Lead sustaining engineering and lifecycle management for assigned product families, drive design changes from R&D into manufacturing, resolve field and manufacturing quality issues, liaise with purchasing/quality/operations, mentor team members, and support cross-functional problem solving to ensure product manufacturability and compliance.
Summary Generated by Built In
Job SummarySalary Range: $100,000 to $115,000 Annually dependent upon education and experience.
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 (Product Sustaining) in this role is responsible for leading life-cycle management / sustaining engineering activities into manufacturing for their assigned product families. This role serves as the primary product lead for R&D, procurement, manufacturing, and quality within the manufacturing facility for product/ design related topics. This role also consists of acting as technical project lead to plan and implement design changes from R&D into manufacturing.
Requires working in a team environment with cross-functional team members, such as manufacturing, quality, regulatory, and other R&D departments.

Responsibilities
  • Technical project lead to plan and implement design change transfers from R&D into manufacturing for their assigned product families.
  • 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.
  • Act as a primary R&D liaison at the manufacturing site for procurement, quality, manufacturing, and operations.
  • Maintains the overall project schedule.
  • Collaborate with cross functional groups to complete Change Control documentation to support the execution of the change into manufacturing.
  • Routinely provides advice and assists team members regarding unique problems.
  • Advise management on proposals and courses of action using both written and verbal methods.
  • Utilize engineering principles, technical analysis, and problem solving tools.
  • Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
  • Mentors, coaches, and assigns tasks to other team members assigned to their product families.
  • 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.
  • Demonstrated project management skills with ability to manage/prioritize multiple concurrent projects.
  • Displays a solid understanding of theories/practices utilized by engineers and from other disciplines outside the primary area of expertise.
  • Strong critical thinking skills and the ability to function in a sometimes-ambiguous situations.
  • Excellent written and verbal communication skills.
  • Experience with MS Project or similar project scheduling tools.
  • 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 Information

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.

Top Skills

Iso 14001
Iso 45001
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The Company
HQ: Bad Homburg
21,388 Employees

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. Fresenius Kabi Community Guidelines and User Information: https://www.fresenius-kabi.com/social-media-terms-conditions Imprint: https://www.fresenius-kabi.com/imprint

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