• Staff Systems Engineer

    Actalent (San Carlos, CA)


    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 SalaryComprehensive health insurance including Medical, Dental and Vision + HSA and FSA optionsEquity & Bonus ProgramLife Insurance (company paid & supplemental) and Disability insuranceMental health support through medical insurance programsLegal and Pet Insurance12+ paid holidays, 15-20 days of PTO + sick time Paid parental leaveIn-office snacks and beverages In-office lunch stipendLearning & Development Opportunities: On-demand online training and book reimbursementTeam 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 [email protected] (%[email protected]) for other accommodation options.