Regulated Medical Device Program Lead (Hardware/Software)

US Tech Solutions; San Bruno (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

US Tech Solutions in San Bruno, CA seeks a seasoned Program Manager for regulated medical device products. The role focuses on bringing hardware and software solutions to market with strict adherence to QMS and regulatory requirements.

The ideal candidate has deep experience in medical devices or SaMD, familiarity with ISO 13485 and FDA 21 CFR 820, and excels in cross-functional leadership across Quality, Regulatory, Engineering and Clinical teams.

Qualifications

• 5+ years of experience in program management.
• Experience in Medical Device Manufacturing or SaMD.
• Experience with Quality Management Systems (QMS).
• 3+ years of technical program management from concept through commercialization.
• Direct experience with devices in a medical regulated industry.
• Excellent communication and project management skills across multiple streams.
• Experience with standards e.g. ISO 13485, FDA 21 CFR 820.
• Experience with hardware, firmware and software products.

Responsibilities

• Provide hands-on project management for regulated medical device products.
• Define production-ready specifications aligned with QMS and regulatory requirements.
• Support regulatory audits and submissions.
• Collaborate with Quality, Regulatory, Engineering, and UX teams for risk assessment and architecture decisions.
• Manage project schedules for cross-functional teams and ensure timely releases.
• Mentor engineers to ensure audit readiness and regulatory compliance.
• Coordinate with Manufacturing, Quality, Regulatory, Clinical, Legal and User Success for complex releases.

Skills

Program management

Regulatory-aligned development

Quality Management Systems

Cross-functional leadership

Education

BA/BS in technical field

Job description

US Tech Solutions in San Bruno, CA seeks a seasoned Program Manager for regulated medical device products. The role focuses on bringing hardware and software solutions to market with strict adherence to QMS and regulatory requirements.

The ideal candidate has deep experience in medical devices or SaMD, familiarity with ISO 13485 and FDA 21 CFR 820, and excels in cross-functional leadership across Quality, Regulatory, Engineering and Clinical teams.