Location: Cleveland, OH
- Support design and development projects for new products, product changes and enhancements.
- Partner with Product Research & Development staff to ensure that products under development are designed for manufacture, assembly, quality, reliability, and inspection.
- Generate and maintain engineering specifications, Requirements, Verifications, BOMs, and labeling.
- Support product development efforts by creating CAD models using SolidWorks and fabricating conceptual and functional prototypes using various methods, including 3D printing, breadboard layout, or simulation.
- Conduct product characterization and document results through formal design analyses or characterization reports.
- Lead prototype and pilot production runs of new products, product changes, and enhancements.
- Provide support to Manufacturing for process validation activities.
- Author and lead team review of Failure Modes and Effects Analyses (FMEs) and Fault Tree Analyses (FTAs).
- Provide support to Manufacturing by utilizing costed BOMs, timed pilot builds and scheduling to establish cost of goods sold (COGS). Identify initiatives to reduce or contain component cost through design improvements/changes.
- Assist with day-to-day operations including vendor identification, quoting, purchasing, receiving, inventory management, and supplier management.
- Degree in mechanical, electrical, biomedical, or a related engineering field is required.
- Experience in medical device development, design transfer, design for manufacturability (DFM), reliability and cost.
- Understanding of medical device DHF, DMR, and DHR files management and documentation requirements.
- Experience in component design, manufacturing, materials, and testing of equipment is required.
- Familiar with manufacturing processes typical of electronic medical equipment, including formed, machined, and molded parts, and automated SMT processes.
- Proficiency in using statistical methods.
- Must be organized and must be able to work on multiple projects with a minimum of supervision and meet established timelines.
- Excellent organizational, interpersonal, oral and written communications skills.
- Proficiency in MS Word, Excel, Visio, MS Project, PowerPoint, SolidWorks.
- Project Management experience
Why Join Our Team?
- Entrepreneurial work environment – A growth oriented and collaborative atmosphere in the medical device industry!
- Ability to work with game changing technology.
- Competitive compensation and benefits.
- Employee Wellness Program.