Fresenius Kabi · 5 hours ago
Sr Mechanical Engineer
North Andover, MA
Full-time
Hybrid
Senior Level, Lead/Staff
$145K/yr - $160K/yr
8+ years expFresenius Kabi is seeking a Senior Mechanical Engineer to join their hardware development team. The role involves planning, analyzing, and implementing designs and improvements to mechanical systems in Ivenix products to meet performance goals and business objectives.
BiotechnologyHealth CarePharmaceutical
No H1B
Responsibilities
This Engineer will design and develop components and subassemblies used in durable and consumable equipment designed by Ivenix. Display standard engineering principles to resolve difficult problems, from conception to final design with team input. Design complex electro-mechanical mechanisms. Define, and demonstrate design meets engineering performance goals
Independently define components, material specifications, and process techniques to ensure proper functionality and long-term performance. Optimize designs for low-cost, high quality, high reliability and high-volume assembly
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
Establish engineering design documentation including Design files, technical records and engineering changes
Identify risks and resolve issues that may negatively impact project schedules and identify solutions to improve project schedules. Investigate new technologies and best practices. Guide the conceptualization of new methodologies and processes into implementation
Prototype, debug, troubleshoot, and/or rework devices while maintaining quality technical documentation. Build and test prototypes to verify design function
Establishes and performs DoE to assess and characterize new solutions and designs
Design and develop processes, tools or fixtures for assembling and testing products
Perform and document failure analysis of returned product
Work with manufacturing departments to ensure final design is properly executed in the creation of mechanical products
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
Qualification
Required
BS or MS Degree in Mechanical Engineering or Biomedical Engineering
8+ years of experience as a mechanical design engineer on product development teams
Direct 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, 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
Benefits
401(k) plan with company contributions
Paid vacation
Holiday and personal days
Employee assistance program
Health benefits to include medical, prescription drug, dental and vision coverage
Life insurance
Disability
Wellness program
Company
Fresenius Kabi
Fresenius Kabi is a health care company, that offers therapy and care of chronically seriously ill people - in and out of hospitals.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Christian Mattis
Chief Financial Officer MedTech NAM
Tanja Greve
CFO BU Biopharmaceuticals
Recent News
2025-12-06
News is my Business
2025-11-19
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