• Risk Control Design Quality Engineer

    Actalent (Fremont, CA)


    Job Title: Risk Control Design Quality EngineerJob Description

     

    Join a dynamic team dedicated to ensuring the highest standards of risk management in design quality. As a Risk Control Design Quality Engineer, you will play a pivotal role in mentoring a team of quality engineers and guiding best practices to enhance product safety and compliance.

    Responsibilities

    + Serve as the subject matter expert in risk management for design quality, guiding junior engineers and cross-functional teams.

    + Lead the development, execution, and maintenance of risk management files in accordance with ISO standards and 21 CFR Part 820.

    + Drive hazard analysis, FMEA (Design and Process), fault tree analysis, and other risk assessment methodologies throughout the product lifecycle.

    + Collaborate with R&D, Regulatory, Clinical, and Manufacturing teams to ensure risk controls are properly implemented and verified.

    + Review and approve design documentation, including Design History Files (DHF), Design Inputs/Outputs, and Verification/Validation protocols.

    + Provide strategic input during design reviews, ensuring risk mitigation strategies are comprehensive and compliant.

    + Lead training and mentoring efforts for junior engineers on risk management principles, tools, and regulatory expectations.

    + Support internal and external audits, including FDA and Notified Body inspections, as the risk management representative.

    + Continuously improve risk management processes and tools to enhance product safety and compliance.

    Essential Skills

    + Expert-level knowledge of ISO standards, 21 CFR Part 820, and related regulatory frameworks.

    + Demonstrated leadership in risk management activities across multiple product development projects.

    + Strong analytical and problem-solving skills with experience in statistical analysis and risk quantification.

    + Excellent communication and interpersonal skills, with a proven ability to mentor and influence cross-functional teams.

    + Experience in EU MDR.

    Additional Skills & Qualifications

    + Bachelor’s or Master’s degree in Engineering, Biomedical Sciences, or related field.

    + Minimum 10 years of experience in Design Quality Assurance and risk management within the medical device industry.

    + Certified Quality Engineer (CQE) or Risk Management certification preferred.

    + Experience with Class II or Class III medical devices.

    + Familiarity with electronic quality management systems (eQMS) and document control platforms.

    + Experience supporting M&A or integration projects from a risk management perspective.

    Work Environment

    Onsite work is required five days a week with core hours from 8 AM to 5 PM. Employees are hired as Salary + Consultants and will receive their straight time hourly rate for all approved hours over 40 in a week. This position offers an opportunity to lead initiatives, make informed decisions, and own your domain in a collaborative and innovative environment.

     

    Job Type & Location

     

    This is a Contract position based out of Fremont, CA.

    Pay and Benefits

    The pay range for this position is $135200.00 - $156000.00/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

     

    • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

     

    Workplace Type

     

    This is a fully onsite position in Fremont,CA.

     

    Application Deadline

     

    This position is anticipated to close on Dec 1, 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.