Principal Mechanical Design Engineer

Ontogen Medtech seeks a Principal 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 and design Creation and review of SolidWorks CAD models and 2D drawings Design for Manufacturability and Assembly Proof of concept hands-on prototype fabrication Design and creation of new test methods and fixtures Tolerance Stackup Analysis DHF documentation preparation Drafting and executing test protocols Conducting prototype tests Gathering, organizing, and reporting test data Regulatory submission preparation Documenting official procedures Frequent interaction with vendors and suppliers to ensure timely completion of deliverables At minimum, candidates will have: BS in Mechanical Engineering, or equivalent 8+ years Medical Device R&D experience Demonstrated mastery of SolidWorks Demonstrated expertise generating product ideas and developing through to production Demonstrated expertise in plastics design for injection molding Experience 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 supervision Excellent oral and written communication skills, particularly in technical writing and documentation Demonstrated organizational, interpersonal, and critical thinking skills. Additionally, the following are highly desirable: MS in Mechanical Engineering, or equivalent Prior experience working in a fast-paced medtech startup environment Ontogen Medtech offers competitive compensation commensurate with each candidate’s experience, as well as benefits including medical insurance, 401k company contribution, quarterly bonus program, unlimited PTO, etc. 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. #J-18808-Ljbffr Ontogen Medtech