Manufacturing Test Engineer (Electro-Mechanical Systems)

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

Job summary

Pulse Biosciences is seeking a Manufacturing Test Engineer in Hayward, CA to oversee manufacturing engineering, production, product support, and service for capital and durable electronic products.

You will partner with R&D and Quality to move products to manufacturing, define MPIs/TPs, perform PFMEA, and develop test fixtures and software to enhance quality and safety. Travel to contract manufacturers may be required.

Qualifications

• Bachelor's degree in Electrical Engineering or equivalent experience.
• 2–5 years in manufacturing operations with at least 1 year in regulated industry (medical preferred).
• Experience with RF systems, IEC 60601, and compliance activities is a plus.

Responsibilities

• Drive manufacturing engineering and collaborate with R&D and Quality to transition products to manufacturing.
• Define operations processes including MPIs, TPs, DHRs, etc.
• Support PFMEA analyses; define and execute process validations.
• Develop test fixtures, procedures, and software to advance product quality and safety.
• Perform test and debug at PCBA and System levels.
• Collaborate with contract manufacturers and external suppliers.
• Apply analytical methods to reduce cost, cycle time, and improve quality.
• Review engineering drawings, schematics, and technical reports.
• Provide SME guidance to R&D for manufacturability through metrics.
• Ensure compliance with company policies and regulatory requirements.
• Support failure investigations with cross-functional teams.
• Root-cause analysis on complex systems across components.
• Execute day-to-day tasks as needed.

Skills

RF Systems

Power systems

Python programming

MatLab

LabView

Electronics assembly & test

ERP/PLM & Lean

Quality/regulatory knowledge

Excellent communication

FDA/ISO regulatory knowledge

Education

Bachelor's degree in Electrical Engineering

Equivalent experience

Tools

Bench test equipment

ERP systems

PLM systems

Job description

Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.

The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit pulsebiosciences.com to learn more.

Why Join Us?

At Pulse Biosciences, we are driven by purpose and innovation.

• Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards. We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.
• Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.
• Our Commitment: Hiring the best and brightest minds to advance our world-class organization.

What You Will Experience

• Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!
• Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!
• Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!
• Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.
• Ownership and Rewards - Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• Work-Life Balance - Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.
• Diversity & Inclusion - A commitment to providing a respectful work environment to our diverse workforce.

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. It is not typical for an individual to be hired at or near the top of the range for their role. 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.

Ready to Shape the Future of Healthcare?

Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation. To learn more about us, visit our website at www.pulsebiosciences.com.

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.