Senior Quality Engineer, Electrical System
Pulse Biosciences (Nasdaq: PLSE) is a bio-electric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. The CellFX® System will be the first commercial product to harness the distinctive advantages of our proprietary Nano-Pulse Stimulation™ (NPS™) technology. The unique cell-specific effects of the NPS mechanism of action have the potential to significantly benefit patients across multiple medical applications, including dermatology, our first planned commercial application.
We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members. We take pride in hiring the best and brightest minds to our world-class company. Individuals who are creative, forward-thinking, and who approach challenges with an innovative attitude will excel in our culture.
The Senior Quality Engineer will participate in design assurance and production activities of CellFX system in support of the Company’s research and development, manufacturing, regulatory, and clinical affairs efforts. In addition, this position will support the continual improvement of the quality system processes and compliance activities.
Essential Duties and Responsibilities
- Provide expertise and guidance to product development and manufacturing teams in the areas of design assurance with emphasis on electrical system.
- Proactively investigate CellFX System failure arising from production processes and customer complaint.
- Actively engage with Electrical Engineering and Manufacturing Engineering to improve system performance, and apply state of the art manufacturing principles to electronic assemblies.
- Participate in the design verification and validation of CellFX System.
- 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.
- Establish and maintain quality engineering methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.
- Develop and validate measurement methods, monitor design control standards, perform statistical analysis and participate in MRB as appropriate.
- Design and implement methods and procedures for inspecting, testing and evaluating electronic assemblies and components.
- Support internal audits and other regulatory compliant activities.
- Support management review activities, Notified Body audits (ISO), FDA audits and assist with preparation of regulatory submission.
- Carry out responsibilities in accordance with the organization’s policies and applicable laws.
- Support the Pulse Biosciences Quality Policy and Quality System.
Education and Experience
- BS degree in electrical engineering or science field or equivalent.
- 10+ years of medical device experience.
Skills, Abilities, and Other Requirements
- Must have experience with FDA QSR (21 CFR Part 820 & Part 11) and ISO 13485/MDD requirements.
- Experience with Medical Electrical Safety and EMC standards (IEC 60601-1, IEC 60601-1-2) and Risk Assessment (ISO 14971: 2012) practices and implementation.
- Knowledge and experience in the following areas:
- Design Control
- Design & Process Validation
- Risk Management
- PCB and assembly manufacturing
- Circuit Design
- Quality system compliance
- Complaint handling
- CAPA management
- Mastered the use of quality disciplines, tools, and methodologies.
- Proficient knowledge and skill in Microsoft Office Suite applications.
- Excellent oral written communication skills, critical thinking skills and project management skills.
- 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.
- Ability to travel up to 10% of the time. Overnight and/or international travel may be required.
- Ability to lift 10-15 pounds.
Our corporate headquarters is located in Hayward, California. To learn more about us, visit our website at www.pulsebiosciences.com.
At Pulse Biosciences, we are committed to providing a respectful work environment to our diverse workforce. 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.
Principals only; unsolicited candidate submissions from recruiters or third-party agencies will be considered free referrals.