PRINCIPAL DEVELOPMENT ENGINEER HARDWARE LEAD

Medtronic (www.medtronic.com), is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic's mission is: To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.

Manage project activities and engineering design team to develop complex electromechanical products from initial definition and planning through production, release, and end of life.

* Manages multidisciplinary engineering design team consisting of 5 to 10 mechanical engineers, electrical engineers, systems engineers, and technicians. * Provides technical direction for team based on an indepth knowledge of design and manufacture of electromechanical systems; including actuator driven mechanisms with embedded sensors, frames and outer caseworks, and human/machine interfaces. * Anticipates, identifies and provides technical solutions to a wide range of difficult problems based on engineering and product development experience. * Inventor and detailed technical contributor for various parts of the system design. * Interface between design team and upper level management, marketing, and other functional groups to communicate project goals, customer requirements, system integration issues, and higher level design intent. * Prepares reports, presentations and spreadsheets of an analytical and interpretative nature to be presented to peers, executives, surgeons, and customers. * Conducts project management tasks & documentation with design controls and risk analysis in accordance with established SOPs. * Conducts and leads product testing and creates models and prototypes. * Establishes, executes, and reports on product development deliverables taking concepts through validation and into commercialization. * Incorporates required regulatory standards (FDA, ISO) in developmental and/or sustaining engineering projects including written protocols, test methods, assembly processes and the Design History File. * Train and mentor others in specialized areas.

* B.S. Engineering, M.S. Engineering or PhD Engineering preferred. * achelor’s plus a minimum of 12 years relevant experience; or Master’s plus a minimum of 10 years relevant experience; or PhD plus a minimum of 8 years relevant experience. Education in Engineering, Scientific or Technical discipline required. Medical device experience strongly preferred. * Thorough understanding of medical device industry and competitor products. Working knowledge of other related disciplines. * Thorough understanding of clinical and regulatory pathways. * Thorough understanding of IP generation and analysis. * Takes initiative in keeping current with technology developments in specialized area. * In depth knowledge and wide application of technical principles, theories, and concepts in related field of expertise to develop innovative approaches to work. * In-depth clinical knowledge for uses of product. * Effectively communicates and works cooperatively with others as part of a team. * Working knowledge of applicable FDA and ISO standards. * In depth knowledge and experience in transferring designs to manufacturing. * In depth knowledge and experience of mechanical design and development of complex delivery systems for medical devices. * Thorough understanding of engineering practices, product safety and root cause analysis. * Knowledge of GMP for tooling, molding, design and process methods. * Working knowledge of rapid prototyping, material selection, and product design and process specs. * Working knowledge of Design for Six Sigma, Failure Mode Effects Analysis, Statistical Analysis methods, and Design of Experiments. * Effective in written and oral communication; experienced in report writing and development of presentations. * Working knowledge of preclinical study designs, execution and interpretation of results. * Functional/Technical Skills * Action Oriented * Self Development * Time Management * Listens & Communicates Effectively * Problem Solving * Customer Focus * Planning * Decision Quality * Organizing * Creativity * n depth knowledge and application of 3D modeling and CAD (Pro/Engineer, ProE) design, Outlook, MS Excel, and MS Word. * Working knowledge of MS project software.