Manufacturing Test Engineer
The Manufacturing/Test Engineer is responsible for manufacturing engineering, production, product support, and servicing to achieve world-class results. Responsible for manufacturing and test engineering as well as line support for production of products.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Drive manufacturing engineering and work closely with R&D and Quality to effectively transition products to manufacturing; serve as a key representative and contributor on a project development team
- Define operations processes, including hands-on definition of MPIs, TPs, DHRs, etc.
- Develop test fixtures, test procedures and software test programs
- Perform test and debug at PCBA and System level
- Work with external suppliers and contract manufacturers for outsourcing subassemblies and assemblies
- Contribute to operations initiatives, apply analytical and statistical methods to continually improve quality, reduce cost, reduce cycle time and simplify processes
- Ensure compliance with company policies, procedures, and regulatory
- Support failure investigations; collaborate closely with cross-functional groups
- Assist in facilities expansion & facilities maintenance as needed
- Collaborate cross-functionally to define product servicing strategy and infrastructure. Establish L1 (service desk) and L2 (break fix) support
- Executing day-to-day tasks as needed
- Other tasks as requested by management
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Medical device experience required
- Technical knowledge of assembly, test and debug of electronic equipment
- Experience in data collection, root cause and failure analysis
- Working knowledge of manufacturing engineering, ERP and PLM systems, quality assurance and lean manufacturing
- Must be flexible, detail oriented, and extremely organized, with a positive outlook, enthusiasm, and high energy; ability to thrive in a rapidly-growing, dynamic, drive-for-excellence environment
- Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other national and international regulations and standards
- Experience at start-up companies preferred
- Excellent communication skills; written, verbal and presentation
- Microsoft Office (Word, Excel, Project, PowerPoint, Visio) skills
- SolidWorks, Adobe Acrobat Professional, Adobe Illustrator, Zebra Printer hardware/software
- A minimum of 5 years experience in one or more disciplines of manufacturing operations (e.g., manufacturing, assembly & test, manufacturing engineering, subcontract, service)
- Bachelor's degree in engineering, manufacturing, industrial engineering, or a related discipline preferred
Pulse Biosciences is a novel medical therapy company bringing to market its proprietary CellFX™ Nano-Pulse Stimulation™ (NPS™) platform. The Company’s CellFX NPS platform provides a novel, precise, non-thermal, treatment technology delivering nanosecond duration energy pulses that impact cells in treated tissue while sparing acellular tissue. NPS’s unique mechanism of action disrupts the functions of internal cell structures while maintaining the outer cell membrane initiating a cascade of events within the cell that results in regulated cell death. The novel characteristics of the Company’s NPS mechanism of action has the potential to significantly benefit patients across multiple medical applications, including dermatology, the Company’s first planned commercial application. In pre-clinical studies, NPS has demonstrated an ability to induce immunogenic cell death in several cancer cell lines. The Company believes its NPS platform may play a role in immuno-oncology as a focal tumor treatment that can initiate an adaptive immune response. More information can be found at www.pulsebiosciences.com.
Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA.
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All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.