Senior Mechanical Design Engineer (Lisle)

Ontogen Medtech seeks a Senior Mechanical Design Engineer to join its product development team to assist with activities related to the development of innovative medical device products in Chicagoland, IL. We are seeking someone with extensive experience in medical device design, development, and manufacturing who is comfortable leading product development projects. This position requires a creative mind and an ability to transform abstract concepts and design challenges into viable product designs.Responsibilities may include:Product conceptualization/ideation and designCreation and review of SolidWorks CAD models/assemblies and 2D drawingsDesign for Manufacturability and AssemblyProof of concept hands-on prototype fabricationDesign troubleshooting and root cause analysisDesign and creation of new test methods and fixturesTolerance Stackup AnalysisDHF documentation preparationDrafting and executing test protocolsConducting prototype testsGathering, organizing, and reporting test dataRegulatory submission preparation supportDocumenting official proceduresFrequent interaction with vendors and suppliers to ensure timely completion of deliverablesAt minimum, candidates will have:BS in Mechanical Engineering, or equivalent5+ years Medical Device R&D experienceDemonstrated mastery of SolidWorks, including surfaces, parametric modeling, etc.Demonstrated expertise generating product ideas and developing through to productionStrong expertise in plastics design for injection moldingExperience with medical device development and FDA quality practices and standards, including ISO 13485;Demonstrated understanding and experience with common medical device packaging materials and techniques, sterilization processes and techniques, sterilization validation, etc.Demonstrated ability to work independently with minimal supervisionExcellent oral and written communication skills, particularly in technical writing and documentationDemonstrated organizational, interpersonal, and critical thinking skills.Additionally, the following are highly desirable:MS in Mechanical Engineering, or equivalentPrior experience working in a fast-paced medtech startup environmentCompensation: base salary range $100k-$130k + bonus, commensurate with experience.Ontogen Medtech offers benefits including medical insurance, 401k company contribution, quarterly bonus program, unlimited PTO, etc.Ontogen Medtech is an equal opportunity employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the U.S. and to complete the required verification document upon hire.