Vacancy expired!
- Leading a multi-disciplinary design team for medical device capital systems and/or integrated SUDs (single use devices) to the successful completion of project goals
- Performing Verification and Validation (V&V) of both capital system and single-use medical devices
- Creating and managing a schedule of technical deliverables in coordination with a project manager
- Translating highly technical results into easily understood recommendations that will influence cross-functional and Principal stakeholders.
- Creating engineering documentation such as Design Requirements, drawings, BOMs, test methods, and technical reports, and coaching others on engineering documentation
- Training and/or providing work direction to technicians and less experienced engineers
- Successful completion of engineering work in product design and development, test methods, research investigation (animal and clinical studies), and report preparation
- Demonstrated knowledge of medical device design controls through coaching and delivery of high quality, high impact deliverables.
- Lead efforts to design in design for manufacturability, test and cost for medical devices.
- Maintain and ensure compliance with design and quality controls
- Interface with customers and business development
- 7+ years product development in lead roles, preferably in medical device industry
- Mechanical Engineering degree or BME with a focus on ME. Bachelors required; Masters preferred
- Demonstrated track record of medical device product development from concept to commercialization.
- Experience within fluids and/or heat transfer would be ideal
- Excellent hands-on mechanical prototyping, debugging, verification, and failure analysis skills
- Working knowledge of mechanical design principles and FDA regulated medical device design controls
- Proficient in CAD software, preferably SolidWorks
Vacancy expired!