Manufacturing Engineer II

Key Responsibilities

• Responsible for managing manufacturing activities and technical operations functions.
• Serve as technical subject matter expert (SME) for all medical device products.
• Collaborate with new product development teams to ensure successful integration of new products into manufacturing.
• Visit external manufacturing sites as needed to provide technical and validation support and training to contract manufacturing organizations.
• Create and maintain technical product specifications, standard work, drawings, bill of materials, batch records, procedures, and Global Unique Device Identification Database (GUDID).
• Lead development, troubleshooting, and manufacturing process improvements with external vendors including preparation of design controls and design transfer.
• Develop product packaging and establishes test requirements per ISO, and ASTM standards.
• Using Lean principles, identify and implement processes to reduce waste and improve manufacturing yield and throughput.
• Responsible to serve as SME for designing, assembling, modifying, and supporting custom designed and off-the-shelf processing equipment.
• Develop, manage, and perform all process validation/verification and equipment qualification activities, including writing protocols, analyzing data, investigating deviations, non-conformances, corrective and preventative actions, and writing reports.
• Develop standard operations procedures (SOP's) to ensure best practices are consistently followed across the organization.
• Identify opportunities and resolve process/service issues; gather, analyze and interpret data to determine root cause or errors/nonconformances and implement appropriate corrective actions.
• Measure assigned performance goals for manufacturing operations. Understand internal business processes and lead cross-functional teams in development of new and improved processes.
• Hold oneself and others accountable to conduct business in a manner compliant with Bioventus' Code of Compliance and Ethics, policies and procedures and internal controls applicable to their role.
• Collaborates with Audit & Risk Management function to identify business risks, and develop and implement preventive strategies for functional area.
• Other duties as assigned.

Education and Experience (Knowledge, Skills & Abilities)

• Bachelor or higher degree in Engineering (preferably Mechanical Engineering) and 2 or more years' experience required.
• Knowledge of applicable state, federal, and international regulatory requirements (i.e. ISO 13485, FDA 21 CFR 820, etc.) for surgical products (i.e. requirements for current good manufacturing practice (CGMP's) for medical devices and biologics.
• Clean room manufacturing experience is preferred.
• Experience in mechanical design of tools, fixtures, and gauges.
• Experience in implementing design to reduce manufacturing costs.
• Experience in Lean concepts, including Root Cause Analysis and DMAIC thinking. Green Belt certification preferred.
• Sound decision making and innovative thinking.
• Excellent communications skills (written and verbal).
• Proficient using MS Office products (Word, Excel, PowerPoint, Visio, Adobe, Outlook).
• Experience using statistical software for data analysis.
• Experience using solid modeling (CAD.CAM) software preferred.
• Experience using document control software.
• Knowledge of SAP or other integrated software application is strongly desired but not required.