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.


Clinical Research Associate

Posted: September 19, 2018

Current Location: Hayward, CA

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POSITION SUMMARY:

Responsible for conducting activities assigned to a Clinical Research Associates (CRA) who helps to assist clinical team for site qualification, selection, monitoring, start-up and close-out visits. Ensures that duties are performed within line Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Evaluate clinical trial resourcing requirements for qualification, training, monitoring and support of sites during the conduct of the trials. The resourcing plan must balance the cost of travel within geographies with expertise within available resources.
  • Develop a monitoring plan for each clinical trial.
  • Liaise with doctors/consultants or investigators conducting the trial as required to insure the study and monitoring activities are meeting expectations.
  • Oversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study.
  • Oversee site activation process for each study.
  • Develop and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate cause and mitigate risk to study.
  • Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
  • Track patient enrollment and recommend solutions to monitoring staff to increase appropriate enrollment of qualified subjects.
  • Provide support for the processing of data queries.
  • Write monitoring visit reports.
  • Develop and execute a plan to close trial sites on completion of the trial and perform associated close­out activities.
  • Ensure adherence to GCP, Standard Operating Procedures (SOPs) and study protocols.
  • Ensure adherence for regulatory compliance of investigational sites with SOPs, FDA regulations, and ICH guidelines.
  • Coordinate with team data management activities.
  • Generate protocol Informed Consent template.
  • Review site Informed Consent forms and site related materials as needed.
  • May prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, Pharmacovigilance Plan, and Informed Consents.
  • Assist with protocol development and study report completion.
  • Assist with CRF development.
  • Assist with investigator meetings.

QUALIFICATIONS / EDUCATION:

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. 

  • Bachelor's degree (BA/BS) or nursing degree (associate of applied science or above). Clinical research or life science degree preferred.
  • Certified as a CRA, e.g. CCRA , CCRP, or other CRA certification strongly preferred.
  • Three or more years of relevant experience with at least two years of experience in medical device.
  • Prior study management experience.
  • Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
  • Demonstrated ability to work independently and in a team environment.
  • Proficiency with MS Office.
  • Excellent oral and written communication skills and strong organizational abilities.
  • Ability and willingness to travel 25% - 50% of the time (internationally and domestically).

Ability and willingness to travel 25% - 50% of the time (internationally and domestically).

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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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Cost Accountant

Posted: September 7, 2018

Current Location: Hayward, CA

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POSITION SUMMARY:

Pulse Biosciences Inc. is seeking for an experienced Cost Accountant who is detailed oriented, organized, and is excited about improving business processes. You will be responsible for the overall financial management of inventory for the company which involves the ongoing analysis of process constraints, target costing projects, margin analysis, and tracking costs back to underlying activities. Responsibilities will involve defining and maintaining cost accounting systems, meeting deadlines for processing information, answering questions and financial reporting requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following is meant to be a representative but not necessarily comprehensive summary of the duties and responsibilities for this consulting position:

  • Develop and maintain product standard costs including cost estimating to standard labor and overhead rates.
  • Responsible for full cycle Cost Accounting monthly close process and all activities to ensure accounts are accurate.
  • Implement and maintain key policies and procedures.
  • Analyze and Monitor Labor/Overhead Absorption on a periodic basis and forecast/model future quarterly absorptions based on build/production plan.
  • Act as liaison & provide on-going support to Operations on process improvements, financial reporting accuracy, financial controls etc.
  • Manufacturing and Overhead variance research, analysis and reporting.
  • Prepare monthly inventory account reconciliations, revenue & cost of goods schedules and analysis.
  • Prepare requirements for physical inventories, inventory reserves & ensure compliance of the cycle count audit and all physical inventories.
  • Supports quarterly/annual audits and SOX controls processes relating to Cost and Inventory (walk-through and testing).
  • Ad hoc projects as assigned

QUALIFICATIONS / EDUCATION:

  • BS/MS in Accounting
  • CPA experience preferred
  • 5+ year’s hands-on manufacturing cost accounting/finance experience.
  • Must possess hands-on functional expertise including working knowledge of Cost Accounting/Control, Inventory and Production Planning.
  • Experience supporting operations and other departments as needed.
  • Strong computer skills with MS Excel, MS Word, MS PowerPoint.
  • Strong analytical, organizational and time management skills with the ability to multitask effectively without compromising the quality of work.
  • Excellent verbal and written communication skills with the ability to interact effectively and communicate with all levels of the company.
  • Efficient, high productivity contributor, professional attitude, detail oriented and team player.
  • Requires occasional weekend and/or evening work, month end close etc.
  • Experience working in a medical device, bio-chemical and/or semi-conductor manufacturing is preferred.
  • Must be detail-oriented, dependable, organized, and service focused.

COMPANY OVERVIEW:

Pulse Biosciences is a publicly listed clinical stage electroceutical company pursuing multiple clinical applications of its proprietary Nano-Pulse Stimulation technology. Nano-Pulse Stimulation (NPS) is a non-thermal, precise, focal tissue treatment technology comprised of nanosecond (billionth of a second) range pulsed electric fields that directly affect the cell membrane and intracellular structures and initiates cell death in treated cells. The initiation of cell death by NPS results in a minimal inflammatory response, which improves healing outcomes and supports the replacement of treated tissue cells with healthy tissue cells. NPS’ unique mechanism of action to initiate cell death has the potential to significantly benefit patients for multiple medical applications in dermatology, immune-oncology, and in other unique tissue targets. In cancerous lesions, NPS has been shown in preclinical models to induce immunogenic cell death (ICD), which exposes the unique antigens of the treated cells to the immune system and enrolls immune system cells, such as cytotoxic T-cells to mount an adaptive immune response.

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

CONTACT:

Send resume to:  careers@pulsebiosciences.com

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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Clinical Research Associate

Posted: September 7, 2018

Current Location: Hayward, CA

read more >

POSITION SUMMARY:

Responsible for conducting activities assigned to a Clinical Research Associates (CRA) who helps to assist clinical team for site qualification, selection, monitoring, start-up and close-out visits. Ensures that duties are performed within line Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP).

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Evaluate clinical trial resourcing requirements for qualification, training, monitoring and support of sites during the conduct of the trials. The resourcing plan must balance the cost of travel within geographies with expertise within available resources.
  • Develop a monitoring plan for each clinical trial.
  • Liaise with doctors/consultants or investigators conducting the trial as required to insure the study and monitoring activities are meeting expectations.
  • Oversee the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study.
  • Oversee site activation process for each study.
  • Develop and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate cause and mitigate risk to study.
  • Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring.
  • Track patient enrollment and recommend solutions to monitoring staff to increase appropriate enrollment of qualified subjects.
  • Provide support for the processing of data queries.
  • Write monitoring visit reports.
  • Develop and execute a plan to close trial sites on completion of the trial and perform associated close­out activities.
  • Ensure adherence to GCP, Standard Operating Procedures (SOPs) and study protocols.
  • Ensure adherence for regulatory compliance of investigational sites with SOPs, FDA regulations, and ICH guidelines.
  • Coordinate with team data management activities.
  • Generate protocol Informed Consent template.
  • Review site Informed Consent forms and site related materials as needed.
  • May prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, Laboratory Manual, Pharmacovigilance Plan, and Informed Consents.
  • Assist with protocol development and study report completion.
  • Assist with CRF development.
  • Assist with investigator meetings.

QUALIFICATIONS / EDUCATION:

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. 

  • Bachelor's degree (BA/BS) or nursing degree (associate of applied science or above). Clinical research or life science degree preferred.
  • Certified as a CRA, e.g. CCRA , CCRP, or other CRA certification strongly preferred.
  • Three or more years of relevant experience with at least two years of experience in medical device.
  • Prior study management experience.
  • Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations.
  • Demonstrated ability to work independently and in a team environment.
  • Proficiency with MS Office.
  • Excellent oral and written communication skills and strong organizational abilities.
  • Ability and willingness to travel 25% - 50% of the time (internationally and domestically).

Ability and willingness to travel 25% - 50% of the time (internationally and domestically).

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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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Regulatory Affairs Manager

Posted: September 7, 2018

Current Location: Hayward, CA

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POSITION SUMMARY:

This position will be responsible for all regulatory activities related to the development and implementation of both US (FDA) and OUS global regulatory strategies to support the submission, filing, and registration of multiple indications in Dermatology and Oncology medical device development assets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. In addition, this position will support the development and implementation of FDA QSR and ISO 13485: 2016 QMS, EU MDR regulatory requirements, and applicable international regulatory compliance activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Develop and implement competitive and effective domestic (US FDA) and global regulatory strategies for various Dermatology, General/Plastics, Immunology and Oncology products including clinical and nonclinical and identify potential risks associated with proposed strategies
  • Manage and participate in the creation, review, assembly and submission of regulatory documentation such as 510ks, Pre-subs, IDEs, HDEs, PMAs, Early Feasibility Study (EFS), Early Access Program (EAP) or Breakthrough Device Designations (BDD), and its international equivalents such as Technical Files, Design Dossiers for CE Marking including amendments/supplements related to clinical trials
  • Oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
  • Interacts with regulatory agency to expedite approval of pending registration
  • Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
  • Serves as regulatory liaison throughout product lifecycle
  • Participates in some of the following: product plan development and implementation, regulatory strategy, product labeling, risk management
  • Ensures timely approval of new medical devices and continued approval of marketed products.
  • Serves as regulatory representative to marketing, research teams and regulatory agencies.
  • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations
  • 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.

  • Bachelor degree in a life sciences, engineering, or related discipline.
  • 8 to 10 years of experience in Regulatory Affairs in the medical device or biotechnology industries, including an in-depth knowledge and understanding of the regulatory environment. Dermatology (aesthetics), General/Plastics Surgery, and Immuno-Oncology (I-O) regulatory experience preferred.
  • Knowledge of current US and EU regulations, including experience preparing, filing, and performing life-cycle management of applications and all supportive amendments, supplements to the United States Food and Drug Administration (US-FDA) in e-submission document format.
  • Experience with health authority meeting preparation.
  • Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have hands-on experience preparing, managing and submitting major regulatory submissions
  • Ability to successfully manage multiple projects and navigate challenges to deadlines.
  • Experience with regulatory intelligence activities and clinical registration databases to support product approval strategies.
  • Good communication skills in both verbal and non-verbal.
  • Have good understanding and proving practices within both FDA QSR and EU MDR//ISO 13485 regulations.
  • Experienced with both high risk device and non-significant risk device classes (Class III/IIb/IIa/II)

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

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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