Duties and Responsibilities: Lead the design and development of new products from concept to successful market launch through cross functional collaboration and in accordance with FDA and international regulations.

• Lead cross-functional project teams to the successful completion of project goals. Work includes ensuring scope of work, costs, schedules, and risks are properly planned, resourced, and managed.
• Establish design goals and specifications based on requirements and user needs. 
• Interact with physicians to transform clinical observations into new device concepts or approaches.
• Monitor progress, provide project updates on a consistent basis and report out and up project progress and status.
• Support the team with all project activities, overview technical challenges, thoroughly analyze problems, identify potential solutions and their ultimate impact on the project and business.
• Design, build and test functional prototypes to demonstrate proof of concept in bench testing and animal studies.
• Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services. Must be willing to travel to vendors for various activities.
• Develop and perform design verification andvalidation activities. Generate test protocols and test reports.
• Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations and ISO 13485
• Mentor junior engineers and technicians.

Education & Certifications:

•Minimum of BS in Mechanical, Biomedical Engineering or directly related scientific discipline.

Work Experience:

•Minimum of 8 years’ experience in a medical device R&D environment is required.

•Minimum of 1 year of experience in project management.

•Knowledge and/or training of project management, QSR, process development and/or design control processes is a plus.

Knowledge, Skills & Abilities:

• Able to read, write and understand English.
• Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
• Self-starter, Productive, highly motivated with “can do” approach.
• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, influencing, and team building.
• Strong listening and assessment skills.
• Strong questioning & problem-solving skills.