Quality Engineer II

About Balt Our purpose is to improve the lives of 150,000 patients in 2026. Balt is a rapidly growing pioneer in the medical device field, collaborating with physicians and institutions to develop elegant neurovascular devices. For 45 years, Balt has led the way in device development, with a broad portfolio of products for stroke and a growing presence in peripheral vascular applications. About this opportunity – Quality Engineer II The Operations Quality Engineer II supports production quality, facilitates the transfer of neurovascular products to production, and manages supplier quality activities. The role involves working directly with production and suppliers, providing moderate support from engineers and managers, and continuously improving manufacturing and supplier quality processes through technical and process innovation. Job Responsibilities Production support of existing products/processes and sustaining work Facilitate efficient operations, optimize processes, and ensure production goals are met Develop process and procedure updates for increased efficiency, quality, and productivity Work with Manufacturing Engineering to resolve equipment or process issues that cause non-conforming products or low yields Analyze nonconforming product, process, and material issues using root cause tools to drive corrective actions Own NCMR and CAPA investigations and corrections/corrective actions Support supplier onboarding and offboarding requests Handle tasks related to supplier changes and management of existing suppliers Spend significant time in the production environment, working closely with operators and Quality Control inspectors Provide feedback to Quality, Operations, Engineering, and R&D on quality issues Review and approve documentation to support production and process improvement Additional Tasks Development project work – design transfer, commercialization of new products, and site manufacturing transfers Interface with New Product Development team in design control projects to integrate new products or processes into existing manufacturing Process development, validation, and verification work, including IQ, OQ, PQ, software validation, test method validation, and Gage R&R Communicate with suppliers to address quality concerns Maintain and develop processes and procedures by writing standard work instructions Qualification Requirements Bachelor’s degree in engineering or science discipline 2+ years of engineering experience in a related field Medical device or pharmaceutical experience Process and equipment qualification knowledge Statistical analysis skill set Highly Desired Qualifications Class II and III implantable medical device experience with focus on neurovascular devices Experience creating and implementing new production line layouts Minitab proficiency Strong background in medical device components using metals, plastics, extrusion, and/or adhesives Demonstrated ability to plan and run projects Skills Required: Attention to detail when reviewing documentation and processes Solid technical writing ability Comfortable working independently and cross-functionally as part of a team Effective communication with production, regulatory, management, suppliers, and others General understanding of Risk Management and FMEAs Understanding of Process Validation (OQ/PQ) and ability to develop test protocols for FDA and ISO requirements Understanding of CAPA process and root cause analysis tools Ability to develop and draft manufacturing documentation (procedures, drawings, BOM, work orders) Familiarity with design control requirements and V&V testing for new product designs Effectiveness with lab equipment, assembly tools, and measurement devices Basic statistical analysis techniques for process capability and equivalence testing Development and qualification of tooling/equipment (IQ/OQ, support, design) Knowledge of Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc. Highly Desired: Experience with catheters, coils, or stents device manufacturing processes and equipment Test Method Validation and/or Measurement System Analysis experience (Gage R&R, Attribute Agreement analysis) Process background (development, capability, optimization, validation) within the medical device industry Equipment and tooling design and optimization using DFM and Six Sigma principles Leading project teams for new product/process development and transfer into manufacturing Knowledge of manufacturing process development from concept to commercialization, including validation and cost/capacity analysis Application of statistical and analytical methods for process development, optimization, and control (SPC, SQC, DOE) Knowledge of SolidWorks for part and fixturing/equipment design Work Environment Normal office conditions with extended computer usage Standard PPE gowning required for cleanroom activities Moderate lifting, extended walking or standing, microscope usage Balt Group is an Equal Employment Opportunity employer. Pay Range: $95,000—$105,000 USD #J-18808-Ljbffr