Engineering Specialist (Mechanical)

301044 Fresenius Kabi USA, LLC; Massachusetts; Hybrid; USD 165,000 - 175,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation/holiday/personal days

Health benefits: medical, dental, and

Vision coverage

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking an Engineering Specialist who will lead the design and development of infusion product hardware. You will apply DoE, GD&T, and DFMEA to deliver reliable, high‑quality systems, coordinating with cross‑functional teams for prototype and transfer to manufacturing.

A strong background in mechanical engineering and regulated environments is essential. The role is hybrid (onsite 3 days per week) in the United States, with a focus on delivering robust mechanical

Qualifications

• BS or MS in Mechanical Engineering.
• 10+ years of mechanical design experience.
• 5+ years in regulated environments (Medical, Aerospace, Military).
• Experience designing complex electro‑mechanical assemblies in SolidWorks or CAD systems.
• Experience selecting materials and fabrication methods based on requirements.
• Experience using PDM to manage drawings per FDA requirements.
• DFM / NPI experience.
• Experience with thermal management, parts design for molding/injection, and reliability.

Responsibilities

• Lead design and development of Infusion products within the hardware team.
• Create and optimize electro‑mechanical mechanisms to meet performance goals.
• Perform DoE to assess new solutions and designs.
• Generate GD&T drawings and manage tolerances and manufacturing capabilities.
• Lead DFMEA and update designs accordingly.
• Collaborate with internal and external teams to prototype and transfer to manufacturing.
• Ensure compliance with Health, Safety, Environment, and Quality management systems.

Skills

Mechanical design

DoE

Leadership

Problem solving

DFMEA

Thermal management

Education

BS or MS in Mechanical Engineering

Tools

SolidWorks

PDM

Job description

Job Summary

The Engineering Specialist is a self-starter who can play a principal role in our development team. In this role you will plan, direct and implement the designs and improvements to the mechanical systems in Fresenius-Kabi products to achieve product performance goals and business objectives. This position is the technical lead for the development and ongoing support of all durable goods designed by Fresenius-Kabi. Mentors and guides experienced engineers and leads team projects.

• Salary Range: $165,000 - $175,000 based on experience
• Position is eligible to participate in a bonus plan with a target of 15% 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.

Hybrid role: 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

Leads the design and development of Infusion products within the hardware team. Designs complex electro‑mechanical mechanisms to achieve engineering performance goals. Establishes and performs DoE to assess and characterize new solutions and designs. Integrates functional elements unto a unified system design. Designs product housings that integrate subsystems into a sleek, ergonomic industrial design. Generates GD&T drawings identifying critical dimensions according to tolerance stack up analysis and manufacturing process capabilities. Performs and leads DFMEA according to product / system functional analysis, and updates designs (3D and 2D) and solutions accordingly. Optimizes designs for low-cost, high quality, high reliability and high-volume assembly. Investigates new technologies and best practices. Establishes best practices for engineering documentation within the mechanical team. Focuses design efforts around improved performance and reduced complexity. Coordinates with internal and external resources to conduct design, redesign, prototype, and transfer to manufacturing activities. Performs and documents failure analysis of returned product to drive product improvements. Works with customers and vendors as needed regarding technical issues. Creates project timeliness for mechanical engineering activities and tracks progress to the schedule. All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.

Requirements

• BS or MS in Mechanical Engineering.
• 10+ years of experience as a mechanical design engineer on product development teams.
• 5+ years of experience developing within a regulated environment (Medical, Aerospace, Military).
• Experience designing complex electro‑mechanical assemblies in SolidWorks or other CAD system.
• Experience in selecting appropriate materials and fabrication methods based on engineering requirements.
• Experience using PDM to manage database and drawing revisions in accordance with FDA requirements.
• Design for Manufacturing (DFM) or New Product Introduction experience.
• Experience with system integration challenges such as thermal management of electronics, machined and injection molded part design, and design for reliability.
• Attention to details, natural inclination to be methodical and hands‑on in a R&D lab environment.
• Task management skills with ability to prioritize multiple assignments.
• Strong problem solving and analytical skills.

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

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.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life. Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

Fresenius Kabi is aware that scammers may attempt to impersonate our recruiters. While we have limited ability to stop these illegitimate efforts, there are some things you can do to protect yourself and not waste time communicating with an imposter. Check the email address – messages from our recruiters will always come from a company account with the Fresenius-kabi.com domain. We have seen imposters send emails using "Fresenius-kaabi.com" which of course includes an extra "a" in "Kabi." Check our website to see if the position you were contacted about is actually posted. Be wary if someone asks you for personal information. We do not need your driver’s license, social security number, or bank account information before we have made you a conditional offer of employment. Refuse to pay any upfront fees. Fresenius Kabi never charges you a fee to apply for a job at Fresenius Kabi. We will not send you an invoice for equipment (such as a laptop) that we promise to order and reimburse you for once you start working. If you have any questions at any stage of the process, contact us at [e-mail]. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.