Hologic, Inc. has an opening in Louisville, CO. Details are as shown below: JOB TITLE: Sr. Product Development Engineer [SPDEAB525] WORKSITE: 331 S. 104 Street. Suite 200. Louisville, CO 80027. *No telecommuting allowed within the U.S. Up to 15% travel to production sites and suppliers. WAGE RANGE: $95,493 - $146,900 annually JOB DESCRIPTION Support the validation, design, development, verification, and launch of biomedical products and electromechanical systems. Research and develop the design and component selection of mechanical sub systems with the goal of producing products that are simpler to manufacture at scale. Contribute towards the next generation of Hologic surgical products including, MyoSure®, NovaSure®, OmniLok®, CoolSeal, Acessa and Fluent®. Design, fabricate, and test prototypes. Document test protocols and results. Provide R&D laboratory support, testing and instrumentation. Design engineering studies. Perform tests, collect data, and interpret results. Own defined components or sub-assemblies of assigned design projects. Leverage CAD for drawings and design. Prepare and maintain compliant engineering documentation. Identify potential suppliers to solve needs for assigned projects. Conduct design review meetings, seeking to freeze components and sub system level assemblies. Draft design verification and validation protocols and reports. Support technical writing of 510K submissions to the FDA and prepare required technical documentation to present information to the FDA. Up to 15% travel to production sites and suppliers. MINIMUM REQUIREMENTS Bachelor's degree or foreign equivalent in Biomedical Engineering, Mechanical Engineering, or related field, and one (1) year of engineering experience in the medical device industry or related. SKILLS REQUIREMENTS Experience must include one (1) year in each of the following: 1) Machined components design, and molded injected parts design; 2) Using design controls to verify and validate designs, including test development and execution, requirements writing, usability, and knowledge of human factors; 3) CAD (SolidWorks); 4) Rapid prototyping for both 3D printing and conventional machine shops; 5) Statistical methods to design experiments and demonstrate design feasibility of solutions; 6) International standards for packaging medical devices and determining medical device biological compatibility (ISO 10993); 7) Performing tolerance stack-up analyses of medium to large mechanical assemblies; and 8) Risk management and failure mode analysis (FMEA). Background checks may be required. APPLICANT INSTRUCTIONS: To apply, email resume to Talent.Operations@hologic.com. Must reference job title and job code.