Staff Systems Engineer
Actalent
Systems Engineer
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.
Medical Device, Jama, Doors, FDA, Systems Engineering, class iii medical devices, class ii
Medical Device, Jama, Doors, FDA, Systems Engineering
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.
Expert Level
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.
This is a fully onsite position in San Carlos, CA.
This position is anticipated to close on Oct 10, 2025.