Sr. Project Manager, Electrical Engineering

About the Company

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 select markets where it could have a profound positive impact on healthcare for both patients and providers.

Why Join Us?

• Culture and Purpose: Purposeful and rewarding work collaborating with bright and curious minds.
• 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 in a startup-like environment.
• Comprehensive Benefits: A variety of health insurance plans, supplemental insurance options, and a 401k retirement savings plan.
• Ownership and Rewards: Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.
• Work-Life Balance: Paid time off, paid holidays, flexible work schedule, wellness program including onsite gym, and mindfulness classes.
• Diversity & Inclusion: A commitment to providing a respectful work environment to our diverse workforce.

Responsibilities

• Lead and manage multiple electrical engineering projects in R&D, ensuring objectives and scope are well defined, resources are allocated appropriately, and project schedules are specified accurately.
• Organize and lead multifunctional teams, accelerate interdepartmental cooperation, and maintain high levels of teamwork to ensure completion of programs on schedule, within budget, and with high quality.
• Lead product development cross-functional project teams from concept to launch, fostering effective teamwork among internal and external stakeholders.
• Manage and mitigate overall project risk through planning, prioritization, and communication of risk issues and critical tasks.
• Provide regular updates to all stakeholders on project status, development progress, and success.
• Serve as a focal point for project resources, resolving issues as needed and escalating as appropriate.
• Develop a deep understanding of the products’ clinical purpose, important features, and technical challenges for assigned projects.
• Develop a deep understanding of the projects' regulatory and quality strategy, as well as prioritization within the company portfolio.
• Monitor project scope, schedule, and costs to ensure alignment with internal stakeholders and vendor commitments.
• Partner with other project managers to align on cross-functional dependencies, shared milestones, and integrated project schedules across hardware, firmware, and software.
• Initiate and implement actions to proactively manage the change control process to meet financial performance targets.
• Ensure completion of quality control and risk management project deliverables according to regulatory, clinical, and manufacturing standards.
• Create and manage variance to published project plans.
• Implement and monitor progress against design control requirements, revising project plans as necessary per SOPs.
• Ensure adherence to timelines, professional standards, and SOPs for all staff allocated to assigned projects, escalating delays as necessary.
• Aid in the development and maintenance of key project performance indicators (KPIs) within the scope of the project contract.
• Support continuous improvement of engineering capabilities through optimizing processes or procedure steps within the scope of design control.

Requirements

• BS degree in Electrical Engineering or other related engineering discipline required.
• 8+ years of experience in electrical-related product development.
• 5+ years of experience in medical device or combination device development, engineering management, project management, and/or technical lead.
• Experience with Design Controls and Medical Device Directive/Regulation.
• Understanding of hardware and software development methodologies.
• Project Management certification is desired.
• Startup experience is a plus.
• Proficient knowledge and skill in Microsoft Office Suite applications including MS Project, SmartSheet, or other planning tools.
• High degree of problem-solving ability, with an understanding of objectives and processes across multi-disciplinary functions involved in medical device development.
• Leadership and management skills demonstrated in a cross-functional team environment.
• Understanding of FDA medical device guidance on Design Controls, MDD/MDR requirements.
• Understanding of medical device development compliant to IEC60601, IEC62304, and ISO14971 standards.
• Strong interpersonal skills for cultivating effective collaborations between team members.
• Ability to work conscientiously and with minimal direction, using good judgment and taking initiative.
• Ability to work as a team member, multi-task, and adapt to changing work priorities in a dynamic, fast-growing company.
• Excellent oral and written communication skills, and critical thinking skills.
• Ability to lift 10-15 pounds.

Pay

Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. Base salary range for this role in Northern California is $150k - $180k.

Benefits

• A variety of health insurance plans and supplemental insurance options.
• 401k retirement savings plan.
• Stock options awards and Employee Stock Purchase Plan (ESPP).
• Paid time off, paid holidays, and flexible work schedule.
• Wellness program including onsite gym and mindfulness classes.