Join a multi-skilled dedicated and talented team developing state-of-the art cardiac arrhythmia monitors, located in Seattle’s richly historic and interesting Pioneer Square neighborhood. In this full-time regular-employee role, work in a small and dedicated team focused on the development and production of Cardiac Monitoring devices.
The right person will be energized by the unique challenges of a medical device startup environment, by interesting complex technical problems, and will have a penchant for continuous improvement and engineering excellence.
Responsibilities:
- Provide electrical manufacturing expertise during the product development process and interface with suppliers and contract manufacturers to ensure successful launch of new products
- Develop electrical manufacturing process instructions to efficiently manufacture BardyDx products at contract manufacturers
- Work with Quality and Regulatory to ensure all standards governing the manufacture of BardyDx medical devices are met throughout the supply chain
- Quickly find solutions to problems found in the existing supply chain
- Identify and implement improvements in new and existing processes and workflows
- Contribute to a collaborative environment, helping to establish lean practices across the organization
- Assist in the fabrication of electrical prototype equipment and product
- Assist in the analysis of field issues, identifying root cause, and folding solutions back into the product design and manufacturing processes.
- Bachelor's Degree in Electrical, Mechanical or Industrial Engineering (or equivalent)
- 7+ years of experience in a medical or other highly regulated manufacturing environment
- Ability to read and understand electrical drawings and basic mechanical blue prints
- Experience creating electrical manufacturing process instructions and workflows
- Experience working with development engineers to ensure products are manufacturable
- Experience successfully introducing new products from development to contract manufacturers or in-house manufacturing
- Experience with sustaining and continuous improvement activities in the supply chain
- Detail oriented with the ability to manage complex projects while sustaining existing manufacturing
- Strong organizational, analytical and communication skills
- Must be a problem solver and team player
Preferred:
- Disposable, single-use, or refurbishable medical device electrical manufacturing experience
- Basic knowledge of IPC-A-610/IPZC-JSTD-001
- SolidWorks experience
- Minitab experience
All your information will be kept confidential according to EEO guidelines.
