• Sr. Development Quality Engineer

    Actalent (Pleasanton, CA)


    Description

    The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety customer satisfaction and organizational success.

    RESPONSIBILITIES

    - Lead and/or support on-time completion of Design Control deliverables

     

    - Support the establishment of objective measurable and verifiable product requirements

     

    - Support Design Verification and Validation planning execution including any cross-functional investigation resolution activities

     

    - Lead Risk Management activities from product concept through commercialization

     

    - Support test method development and lead test method validation activities

     

    - Support manufacturing process development qualification for new product and design changes

     

    - Support the establishment of component specification definitions supplied component sampling plan development and vendor qualifications

     

    - Support biocompatibility and sterilization qualifications

     

    - Support audits and quality system improvement activities

     

    - Support Company initiatives as identified by management and in support of Quality Management Systems QMS Environmental Management Systems EMS and regulatory requirements.

     

    - Comply with U.S. FDA EUMDR and other requirements as applicable.

     

    - Maintain positive and cooperative communications and collaboration with all levels of employees customers contractors and suppliers.

    Basic Qualifications:

    - Bachelors degree in Engineering or Technical Field.

     

    - Minimum of 5 years of experience in RD Process/Manufacturing Engineering and/or Quality with at least 2 years supporting product development.

     

    - Experience in medical devices and associated regulations/standards.

     

    - Experience in test method development and validation

     

    - Experience in preparing risk assessments FMEA and other risk documents.

    Preferred Qualifications:

    - Advanced Degree in Engineering/Technical Field

     

    - Experience in active implantable medical devices.

     

    - Knowledge of requirements management tools e.g. DOORS and use of problem reporting systems e.g. JIRA.

     

    - Working knowledge of statistics and its application to verification and validation?

     

    Skills

     

    medical device, quality engineering, quality assurance

    Experience Level

    Expert Level

    Pay and Benefits

    The pay range for this position is $60.00 - $60.00/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 Pleasanton,CA.

     

    Application Deadline

     

    This position is anticipated to close on Nov 7, 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.