Mechanical Engineer

Medela•McHenry, IL

8d•Hybrid

About The Position

Medela LLC in McHenry, IL is seeking a skilled and creative hands-on Mechanical Engineer to help develop innovative medical devices and enhance existing products. This position offers an opportunity to take ideas from initial concept through prototyping, design refinement and commercialization. The ideal candidate enjoys solving technical challenges, brings fresh ideas to product design and has the ability to turn creative concepts into practical, manufacturable solutions. Medical device experience is preferred. Engineers with strong mechanical design backgrounds in other regulated industries, including automotive and aerospace, are encouraged to apply. The ideal candidate combines strong mechanical design capabilities with a collaborative mindset, and attention to detail.

Requirements

Bachelor's degree in Mechanical Engineering or a related engineering discipline.
Minimum of three years of professional engineering experience.
Strong hands-on experience in mechanical design, materials, analysis and manufacturing.
At least one year of professional CAD experience using Creo, SolidWorks, Siemens NX or a comparable platform.
Working knowledge of GD&T.
Demonstrated ability to develop mechanical design concepts, build and refine prototypes, and translate designs into manufacturable products.
Strong creative problem-solving skills and the ability to evaluate multiple technical solutions.
Ability to manage multiple projects and collaborate effectively with cross-functional engineering teams.
Excellent verbal and written communication skills.

Nice To Haves

Experience designing plastic components, including knowledge of plastic materials and manufacturing processes.
Familiarity with injection molding and design for manufacturability.
Previous product development experience in medical devices or another regulated industry, such as automotive or aerospace.
Familiarity with FDA and ISO requirements, design controls and engineering documentation.
Basic understanding of electromechanical systems and the ability to collaborate with electrical, hardware and software engineers.
Knowledge of medical device sterilization and biocompatibility requirements.
Experience working in a global product development environment.

Responsibilities

Design, develop and improve mechanical components and assemblies for medical devices, with an emphasis on product enhancements and innovation.
Generate creative design concepts through brainstorming, competitive product analysis and technical research.
Develop working models and prototypes, evaluate alternatives and refine designs through multiple iterations.
Create detailed 3D CAD models, engineering drawings and technical specifications.
Apply geometric dimensioning and tolerancing (GD&T) to ensure design accuracy and manufacturability.
Evaluate materials, manufacturing processes and design alternatives, balancing performance, quality, cost and development timelines.
Support the development of plastic components and collaborate with manufacturing teams and suppliers on design solutions.
Support prototype testing and design verification and validation activities to ensure products meet performance and customer requirements.
Prepare and maintain engineering documentation in accordance with applicable quality and regulatory requirements.
Work within a structured Stage-Gate product development process, including design reviews, documentation and project approvals.
Collaborate with Quality, Regulatory and Operations teams to address sterilization, biocompatibility and other product requirements.
Support the transition of product designs into manufacturing and commercialization.
Work closely with mechanical, electrical, hardware and software engineers to ensure successful integration of product components.
Partner with Product Development, Quality, Regulatory, Operations, Supply Chain and external suppliers to achieve project objectives.
Manage engineering responsibilities across multiple projects, balancing technical requirements, timelines and development costs.
Identify and resolve technical challenges, project risks and design changes to maintain project progress.
Participate in supplier evaluations and provide technical input into product cost models and manufacturing decisions.