Fresenius Kabi US North Andover , MA 01845
Posted 2 weeks ago
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 US