Join Our Team

Pulse Biosciences is always looking to add the best and brightest minds to our world-class company. Our team is best suited for individuals who are creative, forward thinking, and who approach challenges with an innovative attitude. If this sounds like a fit for you, we encourage you to explore our current career opportunities below:

To apply for a position send your resume to careers@pulsebiosciences.com.
Principals only; unsolicited candidate submissions from recruiters or third party agencies will not be accepted.


Senior QA Technician/Specialist

Posted: April 2, 2018

Current Location: Hayward, CA

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POSITION SUMMARY:

This position will participate in the implementation and maintaining of cGMP/QSR (21 CFR 820) and ISO 13485 quality systems, quality and materials control activities of PulseTx System, DermaPulseTx System, single-use Applicators and reusable medical devices in support of the Company’s research and development, quality, manufacturing, regulatory, and clinical efforts. In addition, this position will support the development and implementation of complex energy-based medical device systems Class II, III and regulatory compliance activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Develop, establish and maintain quality/materials control methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.
  • Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for clinical and/or commercial distribution.
  • Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Develops processes and tests to determine that appropriate quality control analysis is being performed. Prepares documentation for inspection/testing procedures. Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records.
  • Conducts routine and non-routine analysis, including but not limited to electro-mechanical analysis of raw materials, in-process items and finished product according to established operating procedures. Compiles data for documentation of test procedures that may include stability program testing and reliability studies
  • Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Develop inspection methods, monitor materials processing at various stages for full traceability.
  • Perform statistical and sampling plan receiving and in-process inspection and participate in MRB as appropriate.
  • Manage equipment calibration/preventive maintenance tracking system and processes.
  • Development of standard operating procedures, and training in the areas of quality and materials controls.
  • Supervise and monitor Pulse Biosciences Non-conforming (NCMR) compliance activities. Ensure that NCMR’s are appropriately generated, documented, and closed in a timely fashion as defined in established procedure.
  • Support management review activities, internal audits, Notified Body audits (ISO), FDA audits and other regulatory compliant activities.
  • Assist with sterilization processing activities including sterilization record review, Gamma quarterly audits, and/or EO annual re-validation.
  • Supervise employees as assigned.
  • Carry out responsibilities in accordance with the organization’s policies and applicable laws.
  • Support the Pulse Biosciences Quality Policy and Quality System.

QUALIFICATIONS:

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.

  • Mastered the use of quality control disciplines, tools, and analyzing methodologies.
  • Must have good communication and time management skills.
  • Working experience with FDA cGMP/QSR (21 CFR Part 820 & Part 11) and ISO 13485 quality systems requirements are required. Must also have working knowledge and experience in the following areas: Quality Control, Materials Control, Change Control (ECO), Non-Conforming, CAPA, Sterilization, Packaging, Shelf Life Validation, and general Quality Systems compliance.
  • Preferred experience with IPC-A-610 F Acceptability of Electronic Assemblies and inspection of electro-mechanical systems

EDUCATION and/or EXPERIENCE:

  • This position requires 8+ yrs. medical device experience and an AA/ AS degree in science, technology or equivalent.

COMPANY OVERVIEW:

Pulse Biosciences, Inc. is a clinical-stage medical device company using a novel and proprietary platform technology called Nano-Pulse Stimulation or NPS. NPS can be tuned to induce a variety of cellular responses including secretion, apoptosis and necrosis by modulating the NPS pulse parameters, making it applicable to a wide variety of cell types and therapeutic applications. One of the more promising applications of NPS is the treatment of solid tumors, where pre-clinical data has shown that NPS provides effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death (ICD).

CONTACT:

Submit resumes to: careers@pulsebiosciences.com

 

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Manufacturing Engineer

Posted: January 3, 2018

Current Location: Hayward, CA

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POSITION SUMMARY:

The Manufacturing Engineer is responsible for manufacturing engineering, production, product support, and servicing to achieve world-class results. Responsible for manufacturing engineering and production of both durable and disposable 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
  • Help define operations processes, including hands-on definition of MPIs, TPs, DHRs, etc.
  • Conduct PFMEA analyses; define and execute process validations.
  • Work with external vendors including contract manufacturers
  • 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

QUALIFICATIONS:

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 and test of electronic equipment
  • 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
  • Controlled environment room (CER) experience 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

EDUCATION and/or EXPERIENCE:

  • 1-3 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

COMPANY OVERVIEW:

Pulse Biosciences, Inc. is an immuno-oncology company developing a proprietary oncolytic electroceutical therapy based on its Nano Pulse Stimulation (NPS) platform. Preclinical studies using NPS on solid tumors in murine models has demonstrated that NPS enables effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death.

Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA.

CONTACT:

Send resume to:  Careers@pulsebiosciences.com

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Sr. Mechanical R&D Engineer

Posted: December 1, 2017

Current Location: Hayward, CA

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POSITION SUMMARY:
Senior Mechanical R&D Engineer will be responsible for developing percutaneous and laparoscopic surgical devices for the delivery of high-voltage nanosecond pulsed electric fields.  Responsibilities include: taking concepts from early prototypes to volume production, working closely with surgeons to obtain design feedback in a surgical environment, and developing close ties with new vendors.  You will play a critical role in an early-stage startup environment with a small R&D team

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Design and develop high-volume medical devices that can be manufactured via injection molding, stamping, etching, laser cutting/welding, ultrasonic welding, bonding, etc.
  • Ensure a smooth transition of new products into manufacturing.
  • Manage projects with cross-functional teams following design control processes while generating: requirements/specifications, FMEA/Hazard analyses, design reviews, validation testing, DHFs, etc. 
  • Exhibit a great attitude as a team player who excels in a demanding start-up environment. 
  • Understand the company’s quality policy and quality system requirements applicable to tasks.
  • Comply with company policies/procedures.

QUALIFICATIONS:
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. 

  • Extensive mechanical design expertise with laparoscopic or percutaneous disposable and reusable medical devices.
  • Proven track record of generating minimally-invasive concepts that can be turned into manufacturable products.
  • Fundamental understanding of mechanical engineering theory including: mechanisms, strength of materials, materials, adhesives, and high-volume manufacturing techniques.  Understanding of electronics and circuits a plus.
  • Understanding of electronics and circuits.
  • Previous experience in ensuring a smooth transition to manufacturing.
  • Strong work ethics with a team-oriented mindset.
  • Demonstrated experience in managing internal and external development resources to achieve product development goals.
  • Demonstrated problem solving skills.
  • Comprehensive knowledge of 3-D CAD, including drafting standards and GD&T
  • Excellent verbal and writing skills.  Experience with MS Excel, Word, and Project.

EDUCATION and/or EXPERIENCE:

  • BS or MS in mechanical engineering required.  Five years of relevant experience in medical device industry required.  Startup experience a plus.

COMPANY OVERVIEW:
Pulse Biosciences, Inc. is is an immuno-oncology company developing a proprietary oncolytic electroceutical therapy based on its Nano Pulse Stimulation (NPS) platform. Preclinical studies using NPS on solid tumors in murine models has demonstrated that NPS enables effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death.

Pulse Biosciences, Inc. (PLSE, Nasdaq) corporate headquarters is located in Hayward, CA. 

CONTACT:

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