Sr. Project Manager, Electrical Engineering

Pulse Biosciences•Hayward, CA

9h•$150,000 - $180,000•Onsite

About The Position

The Sr. Project Manager of Electrical Engineering will be responsible for leading and managing multiple electrical engineering projects in R&D, including planning and driving projects to successful conclusion by ensuring that the objectives and scope are well defined, resources are allocated appropriately, and project schedules are specified accurately. The role will organize and lead multifunctional teams, accelerate 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.

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.
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, 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.
Excellent oral, and written communication skills and critical thinking skills.
Ability to lift 10-15 pounds.

Nice To Haves

Project Management certification is desired.
Startup experience is a plus.

Responsibilities

Lead product development cross-functional project teams from concept to launch, fostering effective 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 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 a working knowledge of the prioritization of the projects within the company portfolio, and their 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.
Partner with other project managers to align on cross-functional dependencies, shared milestones, and integrated project schedules across H/W, F/W and S/W.
Initiate and implement appropriate actions to proactively manage the change control process both internally and externally to meet financial performance targets.
Ensure completion of quality control and risk management project deliverables according to regulatory, clinical, and manufacturing standards and requirements.
Create and manage variance to published project plans.
Implement and monitor progress against design control requirements, and revise project plans as necessary per SOPs.
Ensure that all staff allocated to assigned projects adhere to timelines, professional standards, and SOPs, and escalate delays as necessary.
Aid in development and maintenance of key project performance indicators and ensure 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.