Principal Software Quality Engineer

Pulse Biosciences, Inc.; Hayward (CA); On-site; USD 165,000 - 200,000; Full time

Benefits offered by this job

Stock options

Employee Stock Purchase Plan

401k retirement savings plan

Onsite gym

Job summary

Pulse Biosciences, Inc. in Hayward, CA is seeking a Principal Software Quality Engineer to lead quality assurance for the CellFX system software and related regulatory deliverables.

This role demands deep expertise in design controls, validation, and cybersecurity within an FDA-regulated environment. You will drive SW QA methodologies, collaborate with development and manufacturing teams, support regulatory submissions, and help shape quality systems and post-market activities at a fast-growing

Qualifications

• Experience in software QA for medical device or FDA-regulated environments.
• Familiarity with IEC 62304 and ISO 14971 risk management.
• Strong writing skills for test protocols and regulatory documentation.

Responsibilities

• Lead SW QA activities for CellFX software and accessories; ensure verification and validation.
• Develop and maintain SW quality engineering methodologies and practices.
• Support regulatory submissions and cybersecurity assessments.

Skills

SW quality assurance

Software testing

Regulatory compliance

Design controls

Cybersecurity

Documentation

Education

Bachelor's degree in Computer Science/Software Engineering or related field

Tools

Microsoft Office

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 Principal Software Quality Engineer will be responsible for quality assurance activities related to software/system development, verification, validation, and overall system functionality and reliability of the CellFX system and accessories in support of the Company’s research and development, manufacturing, regulatory, clinical investigations, and commercial efforts. In addition, this position will support the development and implementation of quality systems and regulatory filing activities.

To Make An Impact, You Will

• Provide expertise and guidance to product development and manufacturing teams in the areas of SW quality assurance, design controls and compliance.
• Develop, establish and maintain SW quality engineering methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.
• Proactively investigate, identify and implement best-in-class SW quality engineering practices.
• 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 and validate SW methods, monitor medical device SW standards, facilitate and perform SW code review.
• Assist with preparation of regulatory submissions, regulatory assessments related to software changes and cybersecurity.
• Development of SW standard operating procedures, SW test methodologies, and software verification & validation protocols and reports.
• Design and implement methods and procedures for SW release, SW field upgrade, and final quality assurance.
• Work closely with the Software Development Team to plan, schedule, and improve development test processes.
• Work well in a collaborative team environment with other engineers, developers and end users with minimal supervision and ensure understanding and validation of business requirements.
• Perform validation and verification testing of medical devices and equipment in an FDA regulated environment.
• Support internal quality audits, management review activities, Notified Body audits (ISO), and FDA QSIT audits.
• Assist with development of product labeling, translation, and investigator brochures for commercial and clinical studies.
• 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.

To Excel, You Will Bring

• Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering or related field.
• 10+ years hands‑on working experience in the field of SW quality assurance, SW testing, and/or SW development with at least 5+ years working with complex energy-based medical device system and Class III devices with SW. Cardiovascular devices are preferred.
• Familiarity with the use of quality disciplines, tools, and methodologies.
• Working experience with various FDA software validation and Cybersecurity guidance’s and IEC 62304 Software Lifecycle process standard requirements.
• Must have working knowledge and experience in the following areas: Design Control, Design & Process Validation, Risk Management, Cybersecurity, Quality system compliance, Complaint handling, MDR/Vigilance Reporting, and CAPA program.
• ANSI/AAMI/IEC 62304:2006 Medical device software –Software life cycle processes.
• Medical Electrical Safety and EMC standards (IEC 60601-1, IEC 60601-1-2) and Risk Assessment (ISO 14971: 2019) including Cybersecurity practices and implementation.
• The ideal candidate will have background in software test development, test methodologies and test automation for native applications built QNX or Similar OS.
• Good communication skills, including experience writing technical documentation, test protocol, test reports, etc.
• Must have excellent oral and written communication and project management skills.
• Proven ability to independently manage critical projects as part of an interdisciplinary team and navigate challenges to deadlines.
• Hands‑on experience preparing, managing and submitting major regulatory submissions.
• Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.
• Ability to work as a team member, multi‑task and be very flexible to adapt to the ever‑changing work priorities and requirements of a dynamic, fast‑growing company.
• Proficient knowledge and skill in Microsoft Office Suite applications.
• Ability to travel up to 10% of the time. Overnight and/or international travel may be required.
• 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: $165k-$200k. 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.