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.