Manufacturing Engineer

Summary This position focuses on optimizing manufacturing processes to produce medical devices safely, efficiently, and to high quality standards. The role involves heavy day-to-day engagement with manufacturing operations to ensure equipment performs at optimal levels. A key focus will be using data-driven solutions for the continuous improvement of existing and new processes as well as supporting existing products through sustaining engineering activities. Success in this role requires a balance of analytical planning and direct, hands-on implementation and troubleshooting. Primary Responsibilities Work independently and within project teams to establish and achieve manufacturing improvement goals. Drive sustaining engineering activities to ensure performance and adherence to industry standards while maintaining product continuity for customers. Collaborate and coordinate with new vendors for materials, material replacements, supply chain, and equipment needs. Identify and address efficiency bottlenecks and process shortcomings. Lead root cause analysis (RCA) to drive process efficiency and reduce quality defects. Perform data analysis to support and drive decisions for current and future process improvements. Define specifications for new and existing equipment. Assess and qualify new suppliers, conduct technical reviews of materials or machine information. Assess existing equipment to identify safety concerns and recommend necessary upgrades. Identify, secure, and implement updates to equipment to support manufacturing demand. Lead efforts to meet ISO 13485 requirements for process implementation and validation (IQ/OQ/PQ). Ensure manufacturing equipment runs at optimal performance to meet safety, quality, and customer demand requirements. Ensure change management procedures are followed and changes (ECOs) are properly validated and documented per the Quality Management System (QMS). Maintain manufacturing documentation, including component drawings and specifications, inspection plans, bills of materials (BOM), assembly/packaging drawings, SOPs, work instructions, quality plans, and other required documents. Ensure all documentation complies with company quality system and customer requirements. Participation in internal and external quality audits, CAPA investigations, etc., as needed. Education and Experience Bachelor's degree in mechanical engineering (or related field) (ABET-accredited). 3+ years of applied professional experience in sustaining engineering or process engineering. Preferred medical device manufacturing experience, with understanding of ISO 13485 and ISO 14971. Project management experience preferred. Essential Knowledge, Skills, and Abilities Strong mechanical aptitude and high attention to detail. Exceptional indirect leadership and cross-functional influence capabilities. Strong written and verbal communication skills; comfortable presenting data and proposals in meeting settings. Ability to communicate and coordinate with contractors to consult on requirements for process equipment. Remains composed and level-headed in time-sensitive situations and when working with multiple stakeholders, navigating differing perspectives to find collaborative solutions. Ability to prioritize tasks and manage a diverse workload of various project timelines and complexities. Excellent organizational and project management skills. Detailed record-keeping and documentation practices that adhere to the QMS. Working knowledge of GMP, ISO 13485, MDD/MDR compliance, and safety. Awareness or demonstrated use of Lean/Six Sigma tools (FMEA, DOE, Gauge R&R…). Proficiency with SolidWorks (or comparable), including modeling, drawings, and assemblies. Proficiency with MS Office applications. Proficiency in technical writing. Preferred experience in a manufacturing environment, including working around a wide variety of processes and equipment. WillowWood is an Equal Opportunity Employer. Applicants must be currently eligible to work in the United States without requiring employer sponsorship. Relocation not provided. #J-18808-Ljbffr