Job Title: Manufacturing EngineerJob Description Daily work includes engineering support of existing products and processes as well as ongoing improvement activities and projects including cost and efficiency improvement, capacity increases and manufacturing line duplications between sites. Provide support to the Manufacturing organization to facilitate efficient operations within the production area, optimize existing processes, and ensure that production goals are met frequently using lean and six sigma techniques. Further, monitor performance of equipment, machines and tools and correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues. Interface with New Product Introduction, Quality, and Research and Development organizations in design control projects to integrate new products or processes into the existing manufacturing area. Process development, validation and verification work is frequently required – knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, a clear understanding of FDA’s QSR and cGMP, and a good understanding in the application of statistics to process analysis and improvement. Responsibilities + Provide engineering support for existing products and processes. + Lead ongoing improvement activities and projects, including cost and efficiency improvements and capacity increases. + Duplicate manufacturing lines between sites. + Facilitate efficient operations within the production area. + Optimize existing processes using lean and six sigma techniques. + Monitor and correct performance issues in equipment, machines, and tools. + Interface with New Product Introduction, Quality, and Research and Development organizations. + Integrate new products or processes into the existing manufacturing area. + Perform process development, validation, and verification work. Essential Skills + Experience with medical devices, especially class III medical devices. + Proficiency in process validation, equipment troubleshooting, and production support. + SolidWorks expertise. + Knowledge of FDA’s QSR and cGMP. + Strong understanding of statistical and analytical methods for process development. + Bachelor’s Degree in Engineering required. Additional Skills & Qualifications + Experience with catheters, balloons, or stents device manufacturing processes and equipment is a plus. + Ability to develop master validation plans to meet FDA and ISO requirements for class II and class III devices. + Experience with design and process FMEA. + Ability to prepare project plans, specifications, and schedules for new product development. Work Environment For 40 years, our company has been a global leader in the innovation of novel products for the interventional access and treatment of neurovascular diseases. With one of the most comprehensive product portfolios available, our products are used around the world to access and treat multiple disease states including arterial venous malformations, aneurysms, and ischemic stroke. The company offers a medium size company feel with large global company opportunities, exposure to all facets of engineering, and cross-functional team interaction. Pay and Benefits The pay range for this position is $45.00 - $48.00 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 will be accepting applications until Jan 30, 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.