<p>Description</p> <p>This mechanical engineer will work within a cross-functional group developing and improving consumable devices. They will use experience and education to perform the types of engineering activities which are generally considered within the realm of mechanical design of disposable medical devices and any other expertise that might be held by this individual. They are expected to communicate well with other team members and leadership as assigned to meet the goals of the project, the department, and the company.</p> <p>The products and tools used at bioMérieux are complex and highly technical. This engineer will be expected to become an engineering expert on various aspects of our consumer products, and the equipment used to build and evaluate those products. They will be required to use, understand, and create or procure various tools to help better understand our products. They will evaluate new technologies for use in our products and equipment.</p> <p>This role requires a self-starter who can adapt to an often-changing research environment with limited design inputs. Skills of particular interest for this role include mechanical design of high-volume products, specification development, design and testing documentation, and experience with life science products.</p> <p>Essential Duties:</p> <p>This engineer works within a multi-disciplinary project team to develop and maintain FDA regulated medical diagnostic equipment and related systems. This engineer generally works under the leadership of a more experienced individual (e.g. senior/principal engineer, systems engineer, and/or project manager), and is expected to follow department processes and engineering best practices including reviews, etc.</p> <p>General: uses experience and education to perform the types of engineering activities which are generally considered within the realm of firmware engineering. Uses engineering concepts, company SOPs/WIDs, department SOPs/WIDs to solve a variety of engineering problems.</p> <p>Complexity: works on problems of low to moderate scope and complexity.</p> <p>Supervision: receives some oversight from a senior or principal engineer. Eligible to be a discipline lead on a project, may provide mentoring for other engineers.</p> <p>Compliance: perform all work in compliance with company policy and procedure, and within the guidelines of bioMerieux's Quality System. · Documentation: creates and maintains documentation required for FDA regulation and company procedures.</p> <p>Principal Decisions:</p> <p>Makes design and technical decisions subject to review by senior, principal, and other engineers</p> <ul> <li>Design, develop, and improve consumable components for the bioMérieux product lines. </li><li>Become a mechanical engineering expert on the consumable pouch line of products. </li><li>Collect, analyze, and report data to determine performance of the product. </li><li>Contribute to solving complex mechanical engineering problems. </li><li>Generate a variety of technical documentation including technical reviews, studies, executive summaries, and work instructions. </li><li>Work with suppliers to optimize product performance and recommend new materials and technologies. </li><li>Participate in project and team meetings. </li><li>Communicate project status to team members and to management. </li><li>Participate in risk assessments (FMEA, etc.). </li><li>Participate in occasional brainstorming meetings. </li><li>Collaborate across departments to achieve project objectives (Research, Marketing, Manufacturing, Molecular Biology, etc.). </li><li>Perform work in a clean room environment on a frequent basis. </li><li>Proactively consider plans for self-training, and development. </li><li>Perform other duties as assigned. </li><li>Perform all work in compliance with company policy and within the guidelines of the bioMérieux Quality System. </li></ul> <p>Education and Experience Requirements:</p> <ul> <li>Bachelor's degree in mechanical engineering, biomedical engineering, bioengineering, or similar </li><li>Minimum of five years of experience in engineering; experience working for a medical device or life sciences company a plus. </li></ul> <p>Preferred Skills :</p> <ul> <li>Medical device design and testing </li><li>Design for high volume production </li><li>Six Sigma and Lean principles </li><li>FEA simulation tools (mechanical, thermal, fluidics) </li><li>Plastics Design </li><li>Sheet metal design </li><li>Heat transfer </li><li>Molding processes </li><li>Materials (e.g. plastics, aluminum, copper, steel, etc.) </li><li>Machining/CNC </li><li>GD&T </li><li>3D Printing/Prototyping </li><li>DOE design and execution </li><li>Familiarity with PCR testing </li><li>SolidWorks </li><li>Minitab </li></ul> <p>less than 10% travel</p>