Description
Pushing products through FDA approval.
Lead system architecture and requirement definition.
Conduct risk analyses and ensure ISO 14971 compliance.
Integrate subsystems for cohesive performance.
Plan and execute system-level V&V.
Prepare documentation for regulatory submissions.
Drive continuous improvement in systems engineering practices.
Skills
Medical Device, Jama, Doors, FDA, Systems Engineering, class iii medical devices, class ii
Top Skills Details
Medical Device, Jama, Doors, FDA, Systems Engineering
Additional Skills & Qualifications
10+ years in systems engineering, preferably in medical devices.
Strong understanding of regulatory standards and product lifecycle.
Excellent communication and documentation skills.
Willingness to travel up to 20%.
Self-motivated and adaptable in dynamic environments.
Experience Level
Expert Level
Pay and Benefits
The pay range for this position is $158000.00 - $200000.00/yr.
Competitive Salary
Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
Equity & Bonus Program
Life Insurance (company paid & supplemental) and Disability insurance
Mental health support through medical insurance programs
Legal and Pet Insurance
12+ paid holidays, 15-20 days of PTO + sick time
Paid parental leave
In-office snacks and beverages
In-office lunch stipend
Learning & Development Opportunities: On-demand online training and book reimbursement
Team building and company organized social and celebration events
Workplace Type
This is a fully onsite position in San Carlos,CA.
Application Deadline
This position is anticipated to close on Oct 10, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
