Manufacturing Engineer II

Manufacturing Engineer II

Manufacturing Engineer II at Bioventus – responsible for the support and sustaining of existing products and delivering technical service including installation qualification, upgrades, troubleshooting, repair, and preventative maintenance.

• 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 establish test requirements per ISO and ASTM standards.
• Using Lean principles, identify and implement processes to reduce waste and improve manufacturing yield and throughput.
• 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 operating procedures (SOPs) 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.
• Collaborate with Audit & Risk Management function to identify business risks and develop and implement preventive strategies for functional area.
• Other duties as assigned.

• Bachelor or higher degree in Engineering (preferably Mechanical Engineering) and 2+ years of experience.
• Knowledge of applicable state, federal, and international regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820) for surgical products and CGMPs 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 communication 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 applications strongly desired but not required.

Apply now! Hit the “Apply” button to send us your resume and cover letter.

Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. Qualified applicants will be considered without regard to age, ethnicity, disability, gender, veteran status, gender expression, gender identity, nationality, race, religion or sexual orientation. All individuals, regardless of personal characteristics, are encouraged to apply.

• Entry level

• Full‑time

• Engineering and Information Technology

• Biotechnology research, medical equipment manufacturing, and pharmaceutical manufacturing