Manufacturing Test Engineer (Electro-Mechanical Systems)

Pulse Biosciences•Hayward, CA

25d•Onsite

About The Position

Pulse Biosciences is a novel bioelectric medicine company focused on health innovation with the potential to improve patient quality of life. The company's proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology uses nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue. Pulse Biosciences is actively developing its CellFX nsPFA technology for surgical treatment of atrial fibrillation and percutaneously in other markets where it could significantly impact healthcare for patients and providers. The Manufacturing Test Engineer will be responsible for manufacturing engineering, production, product support, and service to achieve world-class results. This role involves manufacturing and test engineering, and line support for the production of both capital and durable electronic products.

Requirements

Bachelor's degree in Electrical Engineering, related discipline or equivalent experience required.
2-5 years of experience in one or more disciplines of manufacturing operations (manufacturing, assembly and test, manufacturing engineering, subcontract, service) with a minimum of 1 year in regulated industry (medical preferred).
Experience in RF Systems desired, Power system background a plus.
Experience with IEC 60601 testing and other compliance activities as required.
Experience in Python programming desired, MatLab and/or LabView a plus.
Strong understanding of bench test equipment (DMM’s, RTA’s, oscilloscopes, power supplies, signal generators).
Technical knowledge of assembly and test of complex electronic equipment.
Working knowledge of manufacturing engineering, ERP and PLM systems, quality assurance and lean manufacturing.
Must be flexible, detailed oriented, and extremely organized, with a positive outlook, enthusiasm, and high energy, ability to thrive in a rapid-growing, dynamic, drive-for-excellence environment.
Must be able/willing to travel to contract manufacturers for process development, training, etc.
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; oral, written, and presentation.
Microsoft Office (Word, Excel, Project, PowerPoint, Visio) skills.
Ability to travel domestically as needed.
Ability to lift 10-15 pounds.

Nice To Haves

Experience in RF Systems desired, Power system background a plus.
Experience in Python programming desired, MatLab and/or LabView a plus.
Experience at start-up companies preferred.

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.
Help define operations processes, including hands-on definition of MPIs, TPs, DHRs, etc.
Support with conducting PFMEA analyses; define and execute process validations.
Work with R&D to develop test fixtures, procedures, and software programs to advance product quality and safety.
Perform test and debug activities at the PCBA and System level.
Work with external suppliers including contract manufacturers.
Contribute to operations initiatives, apply analytical and statistical methods to continually improve quality, reduce cost, reduce cycle time and simplify processes.
Review and interpret engineering drawings, schematics, and technical reports.
Provide SME guidance to R&D for product manufacturability through metric analysis.
Ensure compliance with company policies, procedures, and regulatory requirements.
Support failure investigations; collaborate closely with cross-functional groups.
Collaborate cross-functionally on root-cause failure analysis of complex electronic systems and troubleshooting to the component level.
Execute day-to-day tasks as needed.