Job Title: Manufacturing Engineer Job Description We are seeking a Manufacturing Engineer with expertise in medical device assembly to facilitate the transition of a product to full-scale manufacturing from its frozen design. This role is vital in establishing robust assembly processes, ensuring regulatory compliance, and supporting day-to-day customer interactions during the product’s ramp-up phase. Responsibilities + Introduce new products onto the manufacturing line from a completed/frozen design. + Create and maintain Bill of Materials (BOM). + Conduct Failure Modes and Effects Analysis (FMEA) testing. + Engage in daily interactions with clients to ensure product meets design controls. + Verify equipment installation and specification accuracy (IQ). + Confirm that equipment operates as intended across all specified operating ranges (OQ). + Demonstrate that the process consistently produces acceptable products under real-world conditions (PQ). + Support the use of test fixtures in the manufacturing process. Essential Skills + Experience in manufacturing engineering and new product introduction (NPI). + Proficiency in creating and managing Bill of Materials (BOM). + Strong client interaction skills. + Knowledge of sterilization and packaging processes. + Experience with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Additional Skills & Qualifications + 7-10 years of experience in the medical device industry is preferred. + Experience in manufacturing products with metal and steel hardware, particularly in orthopedic medical devices. Work Environment The position is based in Fremont, CA, at one of two sites - a contract manufacturing plant and a design and development lab. This role offers the opportunity to oversee sustaining projects post-commercialization and gain exposure to innovative products in pre-commercialization. The environment is dynamic, with a focus on growth and new product introduction. Pay and Benefits The 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.