Principal Engineer (Disposables)

Posted 22 Days Ago
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Lake Zurich, IL
Senior level
Healthtech • Pharmaceutical
The Role
The Principal Engineer manages the development and technical project management of single-use disposables for apheresis collection systems. This role involves project planning, leading a team, and providing innovative solutions to complex problems while ensuring alignment with business goals and working cross-functionally.
Summary Generated by Built In

Job Summary

The Principal Engineer performs disposables engineering and technical project management responsibilities for the development, commercialization, and life-cycle management of single-use disposables kits for BU-TCT apheresis collection systems and related disposable products.
Apply specialized knowledge to manage and complete complex projects, including design or process related activities. Develop strategies where clear guidelines do not exist and creative thinking is required. Generate and implement innovative solutions to highly complex problems.
Lead activities to meet business goals by driving quality improvements, meeting delivery requirements and implementing cost reductions and product enhancements. Requires working in a team environment with cross functional team members, such as manufacturing sites, marketing, quality, regulatory and other departments.
Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum.Responsibilities

  • Displays standard engineering principles to resolve difficult problems, from conception to final design with team input.
  • Plans, schedules and leads project assignments in the evaluation, selection and adaptation of various engineering techniques, procedures and criteria with very minimal to no guidance.
  • With very minimal to no guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger complex project; includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups.
  • Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
  • Supervises/coordinates an engineer and/or technicians on assigned work.
  • Advise and convince management on proposals and courses of action using both written and verbal methods.
  • Effectively operate in and facilitate cross-functional teams with minimal guidance.
  • Provides solutions and recommendations that reflect understanding business objectives and cost implications.

Requirements

  • B.S. degree in Engineering (materials, biomedical, industrial, or mechanical) with 5-7 years of specialized experience in the medical disposables/device products field or advance technical degree.

  • Experience in compliant practices of design control and medical device risk management.

  • Excellent verbal and written communication skills.

  • Strong leadership and project management skills.

  • Strong analytical capability and attention to detail.

  • Ability to operate independently and exercise good judgment.

  • Preferred experience with systems design and system integration for complex medical devices 

  • Experience in an FDA regulated industry, especially with medical device products.

  • A solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.

  • Project management skills with the ability to prioritize multiply tasks.

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 match, 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

Engineering
The Company
HQ: Bad Homburg
21,388 Employees
On-site Workplace

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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