Medical Device Program Manager

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

San Bruno, CA

Contract

Job Description

• Client Retinal Service provides high-quality, low-cost access to retinal screening.
• The team develops and deploys hardware and software solutions to help screen for vision threatening eye disease such as diabetic retinopathy.

Responsibilities

• Managing cross-functional or cross-team projects to bring regulated medical device products to market.
• Ensuring product specifications are defined for production and align with Quality System procedures, utilizing expertise in the medical device product development life-cycle, Risk Management, Design/Process Verification, and Validation.
• Supporting product development through knowledge of Quality Concepts (e.g., Statistical Analysis, NC/CAPA, Audits) and US and International Medical Device Regulations & Regulatory Agencies (e.g., FDA, Notified Bodies, etc.), and regulatory audits.
• Performing product qualification and product validation, as well as providing training and mentoring to engineers to ensure audit readiness and regulatory submissions.
• Support bringing novel medical devices from concept to release, manage project schedules, mitigate risks, handle the Design History File, and align with stakeholders.
• Collaborate with Quality, Regulatory, Engineering, and UX teams to evaluate hazards, discuss technical trade-offs, and enhance the product experience.
• Ideal candidates have strong technical aptitude for regulated products with integrated hardware and software, hands-on technical work experience, and experience with Engineering, Operations, Clinical, Quality, and Regulatory teams for successful product deployments.

Top Daily Responsibilities

• Provide hands-on project management, cross-functional coordination, and team communications to deliver excellent program and product outcomes.
• Manage complex schedules for large, cross-functional teams, prioritize tasks, and ensure quick execution of critical work items.
• Align product development activities with technical specifications, relying on data to create superior research and development concepts and products.
• Collaborate with internal teams (Manufacturing, Quality, Regulatory, Clinical, Legal, User Success) to enable complex product releases and ensure quality throughout the product development lifecycle.
• Use your technical background to contribute to design and implementation, and to triage and resolve complex system issues.

Mandatory

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

Desired

• Ability to contribute to technical discussions, especially in the systems architecture and validation domains, and exercise technical and product judgment to independently resolve project issues.

Education

• BA/BS degree in technical field, or equivalent practical experience.

About US Tech Solutions

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com) .

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,

national origin, disability, or status as a protected veteran.