Principal Software Quality Engineer

Pulse Biosciences, Hayward, CA - Onsite +1

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.

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.

Posted pay

$165K–$200K

a year

Compared with similar jobs

This base pay is below the median for principal software engineering jobs in the Bay Area.

Median: $280K a year
Other jobs in the group: 225

We compare the middle of each posted range. This is base pay as posted. The group does not include this job.

Location

Hayward, CA - Onsite +1

Work type

Not given

Level

Principal

Experience

10+ years

Posted

23 days ago

Last check

8 h ago

Job type

Software engineering

The role

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

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.

Principal Software Quality Engineer

The role

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

Principal Software Quality Engineer

The role

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

What You Will Experience

To Make an Impact, You Will

To Excel, You Will Bring

Pay and benefits

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Company facts

Pulse Biosciences

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