Manufacturing Test Engineer (Electro-Mechanical Systems)

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

Benefits offered by this job

Health insurance plans

401(k) retirement savings plan

Stock options awards and ESPP

Paid time off and holidays

Flexible work schedule and wellness on

onsite gym and mindfulness classes

Commitment to diversity & inclusion

Job summary

Pulse Biosciences is seeking a Manufacturing Test Engineer to lead manufacturing engineering, production support, and test for capital and durable electronic products. This role collaborates with R&D and Quality to transition designs to scalable manufacturing, define processes, and validate through PFMEA and process validation.

You will develop test fixtures and software with R&D to advance product quality and safety, perform PCBA/system level testing, and work with contract manufacturers to

Qualifications

• Bachelor’s degree in Electrical Engineering or related discipline.
• 2–5 years in manufacturing operations with at least 1 year in a regulated medical environment.
• Experience with RF systems; power systems a plus.
• Experience with IEC 60601 testing and regulatory activities.
• Python programming desired; MATLAB and/or LabVIEW a plus.
• Strong bench test equipment knowledge (DMM, RTA, oscilloscopes, power supplies, signal generators).
• Working knowledge of ERP and PLM systems; lean manufacturing.
• Willingness to travel to contract manufacturers for development and training.
• Familiarity with FDA regulations, ISO 9001, ISO 13485 and related standards.
• Startup experience preferred.
• Excellent communication, both written and verbal; presentation skills.

Responsibilities

• Drive manufacturing engineering and collaborate with R&D and Quality to transition products to manufacturing.
• Define operations processes including MPIs, TPs, and DHRs.
• Conduct PFMEA analyses and define process validations.
• Develop test fixtures, procedures, and software with R&D to improve quality and safety.
• Perform test and debug at PCBA and system levels.
• Coordinate with contract manufacturers and external suppliers.
• Apply statistical methods to improve quality, reduce cost and cycle time.
• Interpret engineering drawings, schematics, and reports.
• Provide SME guidance on manufacturability through metric analysis.
• Ensure compliance with policies, procedures, and regulatory requirements.
• Support root-cause analysis of failures with cross-functional teams.
• Travel to contract manufacturers for development and training as needed.

Skills

Excellent communication skills

Attention to detail

Highly organized

Ability to travel domestically

Education

Bachelor's degree in Electrical Engineering

Tools

DMM

Oscilloscopes

RTA

Power supplies

Signal generators

Job description

Pulse Biosciences (Nasdaq: PLSE)

Pulse Biosciences is a bioelectric medicine company committed to health innovation. The Company’s proprietary CellFX® nsPFA™ technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.

The Company is developing CellFX nsPFA technology for surgical treatment of atrial fibrillation and selected peri‑cutaneous markets.

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.

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.

Qualifications

• Bachelor’s degree in Electrical Engineering, related discipline or equivalent experience required.
• 2‑5 years of experience in 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, RTA, 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.

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 the Northern California location. Base salary range: $100 K – $125 K. The position is located onsite in Hayward, CA; candidates must reside in the San Francisco Bay Area. No relocation is offered.

Benefits

• Health insurance plans and supplemental insurance options.
• 401(k) retirement savings plan.
• Stock options awards and Employee Stock Purchase Plan (ESPP).
• Paid time off, paid holidays, flexible work schedule and wellness program (onsite gym and mindfulness classes).
• Commitment to diversity & inclusion and a respectful work environment.

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.