Senior R&D Design Engineer

Senior R&D Design Engineer

The Senior R&D Engineer plays a key role in the definition and execution of changes to surgical products by leading project teams through Design History File revision and commercialization activities. The Sr. R&D engineer will work with project management and cross-functional peers to appropriately plan, de-risk, and execute multiple projects simultaneously. The ideal candidate will be internally motivated and personally accountable to project success. They will be able to compile and organize information from multiple sources, determine scope, impact, and risk associated with projects and lead project teams through execution activities. It is expected that the candidate will be capable of completing product documentation compliant with QMS procedures and understand and update product drawings for predominantly mechanical assemblies. The ability to work in a cross functional environment and gather needed information from other functions are critical skills to be successful in this position. The ideal candidate may be able to grow this role into one including people leadership responsibilities.

Project research, planning, requirements development, test planning, and execution to generate auditable Design History Files. Cross-functional leadership to facilitate development activities and honor timelines and budgets as projects advance through the product development process. Generating detailed designs for surgical product concepts in an organized and consistent manner Developing 3D models and drawings in SolidWorks for product designs, assembly fixtures, and auxiliary equipment, leveraging design experience and department design standards and best practices. Developing product assembly documentation as required. Mentor peers and junior engineers and contribute to the culture of growth and development. Support project managers and facilitate project success through project scoping, planning, risk mitigation, team building and execution of activities. Apply design for manufacturing principles to component and device design. Initiate and own document changes for drawings and other controlled documentation.

Bachelor's degree in Engineering or related discipline required, Mechanical / Biomedical (mechanical) Engineering preferred. Minimum of eight (8) years relevant engineering experience in a regulated industry required with medical device development experience required.

Self-starter with strong proactive work ethic, strong organizational skills, and detail-oriented. Ability to seek, collect, and organize project information from multiple business functions and locations. Working knowledge of quality systems and medical device regulations (ISO13485). Experience with Solidworks 3D modeling. Working knowledge and application of ASME Y14.5-2009 Dimensioning and Tolerancing for Engineering Drawings to generate and interpret component and assembly drawings. Strong technical writing and oral communication Analytical thinking and problem solving Basic understanding of statistical analysis (normality, T-test, probability distribution, etc). Knowledge of and expectation of Good Documentation Practices.

TRAVEL REQUIRED : 20%

WORKING ENVIRONMENT : Office / Professional Plant / Manufacturing Remote / Field Laboratory