Senior Mechanical R&D Engineer - Foot & Ankle

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Requirements:

• Bachelor’s degree in mechanical engineering, biomedical engineering or related discipline
• 8 years related experience in product development engineering with a bachelor’s degree; 6 years with a master’s degree
• Proficient in Computer Aided Design (CAD), Solid modelling (SolidWorks preferred)
• Medical Device experience, with proficiency in mechanical design in a highly regulated industry, including deep knowledge of medical device usage by clinicians
• Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow to meet deadlines
• Knowledge of manufacturing methods, including injection molding, screw machining, milling, welding, and sterilization and packaging
• Experienced at applying GD&T and DFM principals to optimize design for cost
• Proficient on basic computer programs: Microsoft Project, Excel, Word, PowerPoint

Responsibilities:

• Plan, conduct and supervise engineering assignments involving several smaller or lower priority projects or one major project, including project management/scheduling
• Lead cross-functional execution across R&D, Quality, Manufacturing, Regulatory, Clinical and Marketing to advance on-time project execution from research through commercialization
• Collaborate with Marketing to perform research and voice of the customer (VOC) to translate, develop and document design inputs and engineering specifications
• Independently research, ideate, innovate, design, develop, acquire prototypes & refine solutions to complex clinical problems
• Lead design surgeon engagements & cadaver labs to rapidly iterate designs
• Analyze, correct & mitigate complex product design issues using independent judgment
• Lead design verification and validating activities by applying industry standards, test strategies and applicable regulations to ensure safety, efficacy and compliance
• Lead & own creation and refinement of engineering documentation, such as the Design History file elements in accordance with the Quality Management System
• Develop and apply detailed clinical procedural knowledge to benchmark market and competitive offerings to create and advance a differentiated customer value proposition
• Work with cross-functional teams and under minimal supervision of an engineer manager or supervisor
• Conduct root-cause investigation and recommend corrective action for product design issues
• Initiates and implements changes in methods, design or process where necessary