Job Title: Manufacturing Engineer **For Immediate Consideration Please Apply to this posting and email your resume to habels@actalentservices.com** Job Description We are seeking a dedicated and experienced Manufacturing Engineer to join our dynamic and growing team. You will be responsible for developing and implementing manufacturing processes, leading efficiency improvement projects, and ensuring compliance with regulatory standards. This role requires a strong background in the medical device industry and experience with process validation and improvement. 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 kaizen events and Lean Six Sigma projects to drive continuous improvement. + 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 with process development, medical devices, and process improvement. + Proven experience in manufacturing process validation. + Excellent communication and technical writing skills for preparing reports and collaborating with cross-functional teams. Additional Skills & Qualifications + Bachelor’s Degree in Engineering or a related field. + Experience supporting Design Transfer and process improvement. + Knowledge of class III medical devices, particularly catheters. Work Environment You will be working in a collaborative, fast-paced medical device manufacturing environment, with a team size of 8. The company is a global leader in breakthrough cardiovascular and endovascular solutions. Work hours are flexible, typically M-F 8:00 - 5:00, but options for earlier or later start times are available (e.g., 6:00 - 3:00, 9:00 - 6:00). Limited overtime is expected. 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 Mar 10, 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.