Manufacturing Engineer

Manufacturing Engineer

We are seeking a Manufacturing Engineer with experience in medical device assembly to support the transition of a product to full-scale manufacturing from the frozen design. This role is pivotal in establishing robust assembly processes, ensuring regulatory compliance, and facilitating day-to-day customer interactions during the product's ramp-up phase.

Responsibilities:

• Support the transition of medical device products from design to full-scale manufacturing.
• Establish and optimize assembly processes to ensure efficiency and compliance.
• Interact with clients daily to ensure product adherence to design controls.
• Create and manage the Bill of Materials (BOM) for new products.
• Conduct Failure Mode and Effects Analysis (FMEA) testing.
• Oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) processes.
• Ensure sterilization and packaging meet regulatory standards.
• Introduce new products onto the manufacturing line, ensuring seamless integration.
• Support and oversee sustaining projects post-commercialization.

Essential Skills:

• Experience in manufacturing engineering, particularly in medical devices.
• Proficiency in New Product Introduction (NPI) processes.
• Knowledge of Bill of Materials (BOM) management.
• Strong client interaction skills.
• Expertise in Failure Mode and Effects Analysis (FMEA).
• Understanding of sterilization and packaging processes.
• Experience with IQ, OQ, and PQ validation processes.
• 3-5 years of experience in the medical device industry, preferred.

Additional Skills & Qualifications:

• Experience in test fixture development.

Work Environment:

This role is based in Fremont, CA, which hosts both a contract manufacturing plant and a design and development lab. The work environment offers exposure to sustaining projects post-commercialization and innovative pre-commercialization products. The team is growing and winning more NPI projects, providing ample opportunities for professional growth and development.

Job Type & Location:

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

Pay and Benefits:

The pay range for this position is $57.00 - $65.00/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 Jan 6, 2026.

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.