Senior 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.

* 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. **Do you have these experiences or skills?** * Bachelor plus a minimum of 12 years relevant experience or Masters 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. **Skills/Qualifications:** * 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. **Skills/Competencies:** * Functional/Technical Skills * Action Oriented * Self Development * Time Management * Listens & Communicates Effectively * Problem Solving * Customer Focus * Planning * Decision Quality * Organizing * Creativity **Other Skills:** * In 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.