Provide leadership in the coordination of the design, development, verification, and documentation of medical device development projects. Serves as primary contact with clients to provide process guidance, technical support and weekly status updates,
- Develop project plans for medical device development projects to satisfy client's expected milestones, budget and deadlines. Track and communicate project status, plans, risks, timelines, and budget on a weekly or ad-hoc basis.
- Serve as point of contact with clients. Prepare for and chair meetings, coordinate site visits and day-to-day client communications, and generate periodic progress reports.
- Coordinate the development, verification, and documentation of medical device development projects according to regulatory standards and CIRTEC’s design control systems.
- Support engineering activities as required including defining product requirements, generating design concepts, prototyping, writing test protocols and reports, participating in risk and hazards management activities, design verification and design transfer.
- Organize and supervise engineers and technicians, and coordinate activities with different functional groups during the design development process (e.g. R&D, document control, quality, design transfer and manufacturing).
- Assist in business development activities with review and/or preparation of project scope, timeline, and budget documents for proposals.
- 5-10 years+ experience in design and development of medical devices, min. 3 years in project management.
- Minimum BS in Mechanical, Electrical, or Biomedical Engineering.
- Experienced in applying various project management tools for tracking development projects against planned budgets and timelines.
- Good computer skills including MS Project, Word, Excel, and Powerpoint.
- Basic CAD skills and ability to fully interpret 3-D models and technical drawings.
- Solid understanding of medical device design controls, standards, and regulations including ISO 13485 and 21 CFR 820.
- Excellent communication skills both verbal and written. Good decision making and problem solving skills.
- Must have experience with designing test methods, writing and conducting test protocols, and generating test reports for medical devices.
- Must have experience in creating presentations and effectively presenting technical concepts to clients and peers.
Local candidates preferred, minimal relocation available
Indeed - 30+ days ago