- Sets direction and communicates vision for product development in support of the research and development of new medical devices.
- Provide technical and project leadership over multiple complex product development projects.
- Lead the effort to maintain a high level of design control and quality for new design projects.
- Work with Marketing and members of Sr. Managament to establish User and Product Requirements.
- Lead the Design Verificaiton and Validation activites of new medical devices in development.
- Develop project plans based on the scope of project.
- Ensure schedules are well planned and followed.
- Review project progress with senior management.
- Prepare and give oral presentations in a group setting.
- As needed, will supervise othertechnicians and engineers and serve as liaison to other company sites or to external organizations, boards, or committees.
- Typically serves as a technical expert (subject matter expert) on platform and complex projects.
- Review and assess projects and processes for potential patent opportunities.
- Assists in special projects as needed.
- Contributes to team effort by accomplishing related duties as requested.
Required Knowledge, Skills and Abilities:
- Mechanical and/or plastics engineeringexperience developing, delivering, deploying and maintaining medical devices as well as past experience in plastic part design and/or mold design are required for this position.
- Excellent communication skills with the ability to present technical information and prepare written reports. Successful management and implementation of projects.
- Must be able to demonstrate competency in leading others in critical thinking, problem solving and analysis and effective technical project leadership.
- Experience in utilizing Six Sigma tools and analysis is preferred.
- Demonstrated ability to troubleshoot and identify opportunities for improvement.
- Experience managing direct reports is preferred.
- BS in Biomedical, Mechanical, Chemical Engineering or other related technical degree, or equivalent work experience.
- A minimum of ten years of product development experience with design controls, process engineering, manufacturing engineering, or other related experience is required.
- Prior experience with the assembly of medical devices (implant and/or disposables) is preferred.
- Strong computer skills including MS Office applications (Word/Excel) are required.