Job Summary The Engineering Specialist (Hardware) will perform mechanical engineering, technical project management and provide guidance/leadership responsibilities in the hardware development team. Lead activities by driving, planning, directing and implementing designs and improvements to the mechanical systems in Fresenius-Kabi infusion devices to achieve product performance goals and business objectives. This position is a technical and functional leadership role within the hardware development team developing strategies and guidelines to generate and implement innovative solutions. Responsibilities Directs and guides the activities for the Hardware Engineering group responsible for the design and development of products as defined by the program goals and objectives. Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results. Complete latitude for independent judgment., guides projects and programs within the hardware development team to solve and troubleshoot issues that range in complexity. Manages groups of individual contributors within the Mechanical and Electrical Engineering functions. Generates and implements innovative solutions to complex problems through the use of multiple disciplines and technical principles. Advises senior management regarding appropriate action. Designs complex electro-mechanical systems to achieve engineering performance goals Designs product housings that integrate subsystems into a sleek, ergonomic industrial design Develops new approaches to complex problems through adaptations and modifications of standard technical principles. Establishes best practices for engineering documentation within the mechanical team Assesses risks and creates test plans around risk priorities; analyzes results, states conclusions, and assesses residual risks after tests are complete; in addition, assesses adequacy of support for conclusions by test results. Coordinates with internal and external resources to conduct design, redesign, prototype, and transfer to manufacturing activities Networks with senior internal and external personnel in own area of expertise to effectively operate and facilitate cross-functional teams. Performs and documents failure analysis of returned product to drive product improvements Work with customers and cross functional groups in customer evaluations, usability tests, clinical studies, and design validation The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 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) •1 year of Engineering staff management experience •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, injection molded part design, and design for reliability 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. Fresenius Kabi (www.CaringForLife.us) 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 40,000 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. Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr 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 Careers@fresenius-kabi.com. Do not use any contact information in an unsolicited email. We look forward to talking to you about joining our team.