Manufacturing Test Engineer (Electro-Mechanical Systems)

Pulse Biosciences; Hayward (CA); On-site; USD 100,000 - 125,000; Full time

Job summary

Pulse Biosciences in Hayward, CA is seeking a Manufacturing Test Engineer to oversee manufacturing engineering, production support, and test for electro-mechanical systems, including PCBA and system-level testing.

The role collaborates with R&D, Quality, and external contract manufacturers to ensure compliance with FDA/ISO standards, develop test fixtures, and improve product quality and efficiency. On-site, travel as needed, with a focus on delivering world-class results.

Qualifications

• Requires a Bachelor's degree in Electrical Engineering or related field.
• 2-5 years in manufacturing operations with medical industry experience preferred.
• Experience with RF systems and power systems is a plus.
• Familiarity with FDA/ISO regulations and compliance activities.

Responsibilities

• Lead transition of products to manufacturing with R&D and Quality.
• Define operations processes and DHRs, MPIs, and test plans.
• Develop test fixtures, procedures, and software for quality and safety.
• Perform PCBA and system-level testing and debugging.
• Collaborate with contract manufacturers and external suppliers.
• Drive quality improvements, cost reductions, and cycle-time reductions.
• Interpret engineering drawings and reports; guide product manufacturability.
• Support failure investigations with cross-functional teams.

Skills

RF Systems

Communication

Travel flexibility

FDA regulations knowledge

Start-up experience

Education

Bachelor's degree in Electrical Engineering

Tools

Python

MatLab

LabVIEW

Bench test equipment

Job description

Manufacturing Test Engineer (Electro-Mechanical Systems)

Hayward, CA - Onsite

About the Role

The Manufacturing Test Engineer is responsible for manufacturing engineering, production, product support, and service to achieve world‑class results. Responsible for manufacturing and test engineering, and line support for production of both capital and durable electronic products.

To Make an Impact, You Will:

• 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.

To Excel, You Will Bring:

• 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.
• Ability to travel domestically as needed.
• Ability to lift 10-15 pounds.

Pay Range:

Compensation is determined based on a wide range of factors including location, job‑related skills, experience, education, and training. This pay range is specific to Northern California location. Base salary range: $100K - $125K. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.

We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.