Sr. Manufacturing Engineer

Are you ready to work for a more active world?

At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives.

The Senior Manufacturing Engineer is responsible for sustaining and managing contract-manufacturing operations by leading the transfer of new products into manufacturing with minimal direction from management. Provides direction and support for existing products including product and process improvements as well as resolving manufacturing issues that occur throughout the product lifecycle. Collaborates with Marketing, R&D, Quality, and Supply Chain to participate in new product launches, supplier audits, and quality improvements. Communicates departmental priorities to stakeholders and assists management in aligning departmental and project priorities.

What you'll be doing

• Responsible for leading projects and managing manufacturing activities and technical operations functions.
• Serve as a technical subject matter expert (SME) for specified medical device products and guidelines for the designated Business.
• Collaborates with new product development teams to ensure successful integration of new products into manufacturing.
• Evaluates and assists management in the selection of new contract manufacturing organizations.
• Visits external manufacturing sites as needed to provide technical and validation support and training to contract manufacturing organizations.
• Create and maintain technical product specifications, drawings, bill of materials, batch records, procedures, and Global Unique Device Identification Database (GUDID).
• Leads technical transfer of proprietary testing methods to suppliers including training and monitoring of processing methods at the suppliers’ manufacturing sites.
• Leads development, troubleshooting, and manufacturing process improvements with external vendors including preparation of design controls and design transfer.
• Develops product packaging and establishes test requirements per ISO, and ASTM standards.
• Using Lean principals, identify and implement processes to reduce waste and improve manufacturing 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.
• Manages engineering activities related to post-market product surveillance throughout product lifecycle.
• Develops standard operating procedures (SOP’s) to ensure best practices are consistently followed across the organization.
• Identifies opportunities and resolves process/service issues; gathers, analyzes and interprets data to determine root cause of errors/nonconformances and implement appropriate corrections/corrective actions.
• Measures assigned performance goals for manufacturing operations. Understands internal business processes and leads cross-functional teams in development of new and improved processes.
• Provide product technical support for contract manufacturers and suppliers.

What you'll bring to the table

• Bachelor’s degree in a related field (engineering, technical, biology or chemistry).
• Demonstrated experience in electromechanical or mechanical engineering is required
• Knowledgeable of applicable state, federal, and international regulatory requirements (i.e., ISO 13485, FDA 21 CFR 820, etc.) for all surgical products (i.e., requirements for current good manufacturing practice (CGMP’s) for medical devices and biologics).
• Clean room manufacturing expertise.
• Mechanical design of tools, fixtures and gauges.
• Implement design for manufacturability to reduce manufacturing costs.
• Perform root cause analysis and corrective actions.
• Sound decision making, innovative thinking.
• Strong project management, planning, and tactical execution.
• 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 applications is strongly desired but not required.
• Minimum 8 years medical device manufacturing experience preferred.
• Minimum 5 years project management and/or contractor leadership with experience preferably in a medical manufacturing or operations role.
• Six Sigma or Lean Certification preferred.
• Experience leading cross-functional teams.

Are you the top talent we are looking for?