<p>Job Title: Project Engineer</p> <p>Job Description</p> <p>We are seeking a talented Project Engineer to lead and conduct activities aimed at improving quality in the design and manufacturing of medical devices and components. The role involves cross-functional collaboration with R&D engineering, manufacturing, technical services, and supply chain to manage quality, compliance, and cost.</p> <p>Responsibilities</p> <ul> <li>Ensure products and product changes comply with regulatory agencies such as FDA, ISO, UL, CSA. </li><li>Create, develop, maintain, and improve the Quality Management System (QMS) for compliance and product quality improvements. </li><li>Apply advanced tools and methods to solve complex problems and contribute to troubleshooting efforts. </li><li>Lead the application of six sigma techniques and drive continuous process improvement. </li><li>Plan, implement, and optimize complex solutions for small to medium-sized projects and teams. </li><li>Influence change across disciplines and define quality metrics, lead investigations, and communicate quality status. </li><li>Participate in cross-functional projects, define KPIs, lead change management as the site-based quality department subject matter expert (SME). </li><li>Facilitate the design and process failure mode and effective analysis (FMEA) process. </li><li>Provide leadership, coaching, and mentoring to the co-op group and other engineers. </li><li>Support, lead, or manage front room and back room for internal and external QMS audits and investigations. </li><li>Understand engineering documentation such as engineering drawings, bills of materials, change orders, testing documents, and DHF/DMR records. </li></ul> <p>Essential Skills</p> <ul> <li>Root Cause Analysis </li><li>Process Failure Mode </li><li>FMEA </li><li>Troubleshooting </li><li>Product Development </li><li>Quality Engineering </li><li>Six Sigma methodologies </li><li>Corrective Action Plans </li><li>Experience with Medical Devices </li><li>Windchill </li><li>Creo </li><li>SolidWorks </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Bachelor's Degree in Engineering </li><li>Understanding of manufacturing processes in product development, including root cause analysis, corrective actions, and validation/verification testing </li><li>Six Sigma certification </li><li>Medical Device experience </li></ul> <p>Work Environment</p> <p>This position is based in Versailles, OH, requiring work from the office five days a week. The team consists of 7-8 individuals, with approximately 5% travel, mainly local.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $48.08 - $57.69/hr.</p> <p>Eligibility requirements apply to some benefits and may depend on your job</p> <p>classification and length of employment. Benefits are subject to change and may be</p> <p>subject to specific elections, plan, or program terms. If eligible, the benefits</p> <p>available for this temporary role may include the following:</p> <ul> <li>Medical, dental & vision </li><li>Critical Illness, Accident, and Hospital </li><li>401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available </li><li>Life Insurance (Voluntary Life & AD&D for the employee and dependents) </li><li>Short and long-term disability </li><li>Health Spending Account (HSA) </li><li>Transportation benefits </li><li>Employee Assistance Program </li><li>Time Off/Leave (PTO, Vacation or Sick Leave) </li></ul> <p>Workplace Type</p> <p>This is a fully onsite position in Versailles,OH.</p> <p>Application Deadline</p> <p>This position is anticipated to close on May 15, 2025.</p> <p>About Actalent</p> <p>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.</p> <p>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.</p> <p>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.</p>