Job Description
We are seeking a Quality Engineer with a background in design transfer and sustaining engineering to support the launch and scale-up of a new medical device. This role requires close collaboration with Manufacturing Engineering to ensure a seamless transition from design to production, emphasizing quality systems, risk management, and regulatory compliance.
ResponsibilitiesWork closely with the manufacturing engineer to ensure the client's design is accurately translated onto the manufacturing line.Conduct risk assessments and execute FMEA testing.Perform sterilization (Gamma type) on products.Create and manage Bill of Materials (BOM).Verify that equipment or systems are installed correctly and according to manufacturer specifications (IQ).Confirm that the equipment or system operates as intended across all specified operating ranges (OQ).Demonstrate that the entire process, using the qualified equipment, consistently produces acceptable products under real-world conditions (PQ).Essential SkillsProven experience in design transfer.Experience with risk assessments and FMEA testing.Knowledge of quality management systems (QMS).Proficiency in IQ, OQ, PQ processes.Experience working with metal and steel hardware.Additional Skills & QualificationsExperience with orthopedic companies or surgical robotic companies.Familiarity with sterilization processes, specifically Gamma type.Work Environment
Located in Fremont, CA, this position offers the opportunity to work at two distinct sites: a contract manufacturing plant and a design and development lab. The design and development site is currently expanding and gaining more NPI projects, providing exposure to innovative products in pre-commercialization as well as overseeing sustaining projects post-commercialization.
Pay and BenefitsThe pay range for this position is $57.00 - $72.00/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 Aug 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 actalentaccommodation@actalentservices.com for other accommodation options.