Manufacturing Engineer

WillowWood•Mt Sterling, OH

About The Position

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.

Requirements

Bachelor's degree in mechanical engineering (or related field) (ABET-accredited)
3+ years of applied professional experience in sustaining engineering or process engineering
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

Nice To Haves

medical device manufacturing experience, with understanding of ISO 13485 and ISO 14971
Project management experience preferred

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