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Posted 10 hours ago
Senior Project Manager, Electrical Engineering
Pulse BiosciencesSr. Project Manager, Electrical Engineering
Requirements
BS in Electrical Engineering, 8+ years electrical product development experience, 5+ years medical device development experience, Knowledge of Design Controls and MDD/MDR, Understanding of IEC60601, IEC62304, and ISO14971
Skills
Electrical EngineeringProject ManagementMedical Devices
About the role
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™ technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
Responsibilities
- Lead product development cross-functional project teams from concept to launch
- Manage and mitigate overall project risk through planning and prioritization
- Provide regular updates to stakeholders on project status and development progress
- Monitor project scope, schedule, and costs to ensure alignment with internal and vendor commitments
- Partner with other project managers to align on cross-functional dependencies across H/W, F/W, and S/W
- Implement and monitor progress against design control requirements
- Ensure completion of quality control and risk management deliverables according to regulatory and manufacturing standards
- Support continuous improvement of Engineering capabilities
Requirements
- BS degree in Electrical Engineering or a related engineering discipline
- 8+ years of experience in electrical related product development
- 5+ years of experience in medical device or combination device development, engineering management, or project management
- Experience with Design Controls and Medical Device Directive/Regulation
- Understanding of hardware and software development methodologies
- Proficiency in Microsoft Office Suite, MS Project, or SmartSheet
- Understanding of FDA guidance, MDD/MDR, IEC60601, IEC62304, and ISO14971 standards
- Ability to lift 10-15 pounds
Preferred Qualifications
- Project Management certification
- Startup experience
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Get started — it's freeSenior Project Manager, Electrical Engineering
Pulse Biosciences · Hayward
