Principal Engineer (Sustaining Hardware)

Fresenius Kabi USA

Warrendale (Allegheny County)

On-site

USD 100,000 - 115,000

Full time

14 days+

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Benefits offered by this job

401(k) plan with company contributions

Paid vacation and holidays

Employee assistance program

Health benefits including medical, dental, and vision

Job summary

A leading medical device company is seeking a Principal Engineer (Sustaining Hardware) to lead engineering activities for infusion pump products. This role requires a Bachelor's degree in Mechanical Engineering and at least 5 years of experience in medical device design. Responsibilities include project management, problem-solving, and collaboration with cross-functional teams. The position offers a competitive salary ranging from $100,000 to $115,000 per year, along with comprehensive benefits, including health coverage and a 401(k) plan.

Qualifications

5+ years of experience in design and support of complex electro-mechanical devices.
Ability to manage and prioritize multiple concurrent projects.
Experience with regulatory guidelines in the medical device industry.

Responsibilities

Lead project teams through planning and execution.
Provide subject matter expertise in mechanical engineering.
Collaborate with cross-functional groups on project documentation.

Skills

Project management skills

Problem solving

Excellent communication skills

Attention to detail

Collaborative teamwork

Education

Bachelor’s degree in Mechanical Engineering

Tools

MS Project

Job description

Principal Engineer (Sustaining Hardware)

Join to apply for the Principal Engineer (Sustaining Hardware) role at Fresenius Kabi USA.

Base pay range

$100,000.00/yr - $115,000.00/yr

The Principal Engineer (Sustaining Hardware) will perform sustaining engineering activities and technical project management related to commercial infusion pump products for the Ivenix Infusion System portfolio with minimal supervision.

Apply specialized knowledge to manage and complete complex projects, including design and/or process related activities. Develop strategies where clear guidelines do not exist and creative thinking is required. Generate and implement innovative solutions to mid to highly complex problems.

Lead activities to meet business goals by driving quality improvements, addressing material obsolescence, meeting delivery requirements, and implementing cost reductions / product enhancements. Requires working in a team environment with cross‑functional team members, such as manufacturing sites, marketing, quality, regulatory, and other R&D departments.

The position reports to the Director, Program Management. May provide guidance and leadership to junior engineers and manufacturing plant technical staff.

Position is eligible to participate in a bonus plan with a target of 8% of the base salary (include only if applicable to the grade level)
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. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

This position will be located in Lake Zurich, IL or Warrendale, PA and is onsite 3 days per week.

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

This Engineer 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.

Displays a solid understanding of engineering principles to resolve difficult problems, from conception to final design with team input.

Provide subject matter expertise in the areas of mechanical engineering related to electro‑mechanical and devices and associated manufacturing processes. Serve as Technical Approver for product design and/or manufacturing process changes related to infusion pump commercial products.

Plans, schedules, and leads project assignments in the evaluation, selection, and adoption of various engineering techniques, procedures, and criteria with minimal to no guidance.

Maintains the overall project schedule and budget.

Collaborate with cross‑functional groups to complete Change Control documentation to support the execution of the project.

Identifies solutions to complex problems through adoptions and modifications of standard technical processes.

Coordinates engineers / technicians / manufacturing plant personnel on assigned work.

Advise management on proposals and courses of action using both written and verbal methods.

Effectively operates in and facilitates cross‑functional teams with minimal guidance.

Provide solutions and recommendations that reflect understanding of business objectives and cost implications.

All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements

Bachelor’s degree in Mechanical Engineering (or related Engineering degree) and 5+ years related experience in design and support of complex electro‑mechanical devices, preferably in FDA regulated medical device industry
Demonstrated project management skills with ability to manage / prioritize multiple concurrent projects
Experience with theories and practices utilized by other disciplines outside of primary area of expertise
Ability to work as a collaborative team member
Excellent attention to detail and working knowledge of applicable regulatory guidelines and standards
Strong problem solving and analytical skills
Excellent written and verbal communication skills
Experience with MS Project or similar project scheduling tool

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.

Seniority level