NeuroPace · 8 hours ago
Senior Manager, Risk Management & Post Market Surveillance (TPLC)
Mountain View, CA United States
Full-time
Onsite
Senior Level
$160K/yr - $210K/yr
5+ years expNeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy. They are seeking a Sr. Manager, Risk & Post-Market Surveillance to drive post-commercialization risk management and data-driven safety analytics as part of their quality system.
Health CareManufacturingMedical DeviceNeuroscience
Responsibilities
Serve as a subject matter expert in post-commercialization risk management processes and data-driven safety analytics
Maintain ISO 14971-compliant risk files, developing global Post-Market Surveillance plans, and leverage advanced statistical tools to detect emerging performance signals
Implement, instruct, and, where applicable, support training of staff on risk management remediation directives based on findings and analysis with a strong focus on post-market field use of product(s)
Ensure all ongoing maintenance, continuous improvement and remediation efforts meet applicable quality and regulatory standards
Drive change across the organization to ensure cross-functional stakeholders align and integrate recommended risk remediation activities based on data-driven analysis
Lead cross-functional efforts and meetings to analyze and synthesize complex data into actionable insights for senior leadership and other key stakeholders to drive total product lifecycle improvements through the product development pipeline
Qualification
Required
Bachelor's degree in engineering (software engineering preferred) with experience in statistics
Master's degree in related field (Engineering, Statistics, or Analytics) or equivalent job experience
Minimum of 5+ years of experience in medical device risk management
Strong working knowledge of FDA, EU MDR and IMDRF PMS regulations, including international standards such as ISO 14971, ISO 13485, FDA 21 CFR Part 803/ 820
Proficiency in statistical analysis and visualization tools (such as MS Power BI, R, JMP, JAMA, Minitab, SAS, or Python)
Proven experience interpreting post-commercialization product use data and planning total quality systems response(s) to findings
Strong technical writing, communication, and project management skills
Ability to work independently and as part of a cross-functional team
Benefits
Medical, Dental & Vision Insurance
Voluntary Life
401K
RSU
529 plan
ESPP Program
Health & Wellness Program
Generous Paid Time Off plus eleven paid holidays
FSA & Commuter Benefits
Company
NeuroPace
NeuroPace develops and markets implantable devices for the treatment of neurological disorders.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$457.1MKey Investors
MidCap FinancialNational Institutes of HealthAccelmed
2025-06-04Post Ipo Debt· $75M
2025-02-14Post Ipo Equity· $74.8M
2021-06-30Grant· $9.3M
Leadership Team
Joel Becker
President and CEO
Lisa Andrade
Independent Director
Recent News
2026-01-20
2026-01-15
Company data provided by crunchbase