Principal Software Quality Engineer

pulsebiosciences; Hayward (CA); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Health insurance

401k retirement plan

Supplemental insurance

Job summary

Pulse Biosciences seeks a Principal Software Quality Engineer to oversee software quality assurance for the CellFX system and accessories. You will guide verification/validation, design controls, and regulatory filings across R&D, manufacturing, and clinical investigations.

The role requires a strong background in SW QA for medical devices, collaboration with development teams, and support for cybersecurity and labeling activities in an FDA-regulated environment.

Qualifications

• Bachelor's degree is required.
• Experience in software quality assurance within medical devices is preferred.
• Familiarity with design controls and regulatory expectations is expected.

Responsibilities

• Provide expertise in SW QA, design controls, and compliance for product development and manufacturing.
• Develop and maintain SW QA methodologies and processes.
• Support regulatory submissions and cybersecurity assessments.
• Lead software verification, validation, and release activities.
• Coordinate with cross-functional teams to ensure product quality across the lifecycle.

Skills

SW quality assurance

Design controls

Regulatory compliance

Software verification & validation

Cybersecurity awareness

Education

Bachelor's degree in

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