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 Project Manager will lead and manage multiple projects in R&D. This incumbent will also plan and drive projects to successful conclusion by ensuring that the objectives and scope are well defined, resources are allocated appropriately, and project schedules are specified accurately. Organize and lead multifunctional teams, catalyze interdepartmental cooperation, and maintain high levels of teamwork in required activities ensuring completion of the program on schedule, within budget constraints, and with high quality.
Essential Duties and Responsibilities:
- Lead project team(s) and facilitate Engineering’s development progress through the extended project team(s), fostering effective cross-functional teamwork among project team members including both internal and external stakeholders where applicable.
- Manage and mitigate the overall risk of projects through planning, prioritization, understanding of and communication of risk issues and critical tasks.
- Provide regular updates to all stakeholders on project status, development progress, and project success.
- Serve as a focal point for project resources, within area of project responsibility, to internal and external stakeholders as appropriate, resolving issues as needed.
- For assigned projects, develop a deep understanding of the product(s) clinical purpose, important features, and technical challenges.
- Develop a deep understanding of the project(s) regulatory and quality strategy, as well as a working knowledge of the prioritization of the project(s) within the company portfolio, and its delivery to the market.
- Monitor project scope, schedule, and costs to ensure all remain on track to the satisfaction of internal stakeholders, contract or vendor commitments, and with financial performance targets; Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.
- Ensure completion of quality control and risk management project deliverables according to regulatory, clinical, and manufacturing standards and requirements.
- Create and manage variance to required project plans. Per SOPs, implement and monitor progress against design control requirements, and revise project plans as necessary; Ensure that all staff allocated to assigned project(s) adhere to professional standards and SOPs, providing performance feedback to team member’s respective supervisors.
- Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract.
- Support continuous improvement of Engineering capabilities through optimizing processes or procedure steps within the scope of design control.
- Define and manage project resource needs for key resources.
Education and Experience:
- BS degree in Engineering, or BS in a related field applicable to medical device development.
- 8+ years’ experience in product development.
- 5+ years’ experience in medical device or combination device development.
- 3+ years’ experience in engineering management, project management, and/or technical lead.
Skills, Abilities, and Other Requirements:
- Experience with Design Controls and Medical Device Directive/Regulation.
- Understanding of hardware and software development methodologies.
- High degree of problem-solving ability, with an understanding of objectives and processes across multidisciplinary functions involved in medical device development.
- Leadership and management skills demonstrated in a cross-functional team environment.
- Solid 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, 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, including MS project or other planning tool.
- Excellent oral, and written communication skills and critical thinking skills.
- Project Management certification is desired.
- Startup experience is a plus.
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.