Job Title: Manufacturing Engineer

Job Description

We are seeking a skilled Manufacturing Engineer to join our dynamic and innovative team. This role focuses on improving production processes and ensuring compliance with quality and regulatory standards. You will lead efficiency improvement projects and collaborate with cross-functional teams to align project goals and timelines.

Responsibilities

• Conduct time studies and analyze production data to identify areas for improvement.
• Lead efficiency improvement projects and track their impact on production processes.
• Work closely with cross-functional teams, including marketing, IT, and customer service, to ensure alignment on project goals and timelines.
• Monitor and report on key performance indicators (KPIs) such as First Pass Yield (FPY), cycle time reduction, and cost savings.
• Facilitate continuous improvement events and Lean Six Sigma projects.
• Ensure compliance with regulatory standards and quality requirements in all manufacturing processes.
• Develop and implement robust manufacturing processes for existing products.
• Ensure a seamless transition from product development to full-rate production, ensuring process stabilization.
• Develop and qualify new tooling and equipment to enhance production capabilities.
• Design and draft workspace layouts, including materials and equipment, using computer-aided design (CAD) software.
• Update risk documents (FMEA’s) and Quality Control Plans for New Product Introduction.
• Conduct verification and validation (IQ/OQ/PQ) of processes, machines, and equipment to meet company procedures and regulatory requirements.
• Create and maintain routers and standards for manufacturing processes.
• Troubleshoot product and process-related issues, performing root cause analysis and implementing corrective and preventative action plans.
• Collaborate with vendors to identify and implement operational equipment and automation solutions.
• Develop and manage project plans for major operational improvement activities.

Essential Skills

• 3-5 years of experience working as a Manufacturing Engineer in the medical device industry.
• Experience in process development and process improvement.
• Supporting design transfer and process improvement for Class III medical devices, including catheters.
• Proven experience in manufacturing process validation.

Additional Skills & Qualifications

• Bachelor’s Degree in Engineering or a related field.
• Excellent communication and technical writing skills for preparing reports and collaborating with cross-functional teams.

Work Environment

The role is situated within a medical device manufacturing environment, renowned for its breakthrough cardiovascular and endovascular solutions. The team consists of 8 members and operates Monday to Friday, with flexible hours from 8:00 AM to 5:00 PM, accommodating earlier or later start times such as 6:00 AM to 3:00 PM or 9:00 AM to 6:00 PM. Limited overtime is expected. The work environment is collaborative and fast-paced, fostering innovation and growth.

Pay and Benefits

The pay range for this position is $45.00 - $55.00/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 Irvine,CA.

Application Deadline

This position is anticipated to close on Jun 25, 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.