Manufacturing Engineer

at  Bioventus

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 Manufacturing Engineer is responsible for support and sustaining of existing products. The position is also responsible for delivering technical service of products including: installation qualification, upgrades, troubleshooting, repair and preventative maintenance. The responsibilities also include optimizing system performance to minimize equipment downtime and to ensure maximum overall customer satisfaction.

What you’ll be doing

• Responsible for managing manufacturing activities and technical operations functions.
• Serve as technical subject matter expert (SME) for all medical device products.
• Collaborates with new product development teams to ensure successful integration of new products into manufacturing.
• Visits 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).
• 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 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.
• Develops standard operations 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 or errors/nonconformances and implement appropriate 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.
• Holds 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.
• Other duties as assigned.
• Collaborates with Audit & Risk Management function to identify business risks, and develop and implement preventive strategies for functional area.

What you’ll bring to the table

• 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.

Bioventus requires proof that new hires be fully vaccinated against COVID-19, unless you are approved for a reasonable accommodation based on disability, medical condition, pregnancy, or religious belief that prevents you from being vaccinated where allowable under the law. Documentation is required to be uploaded within the first week of employment.
Are you the top talent we are looking for?
Bioventus is committed to fostering an inclusive and diverse community of employees with a strong sense of belonging. We believe we are bettered by all forms of diversity and take pride in working with top talent from every walk of life. In the spirit of inclusivity, 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.

• Responsible for managing manufacturing activities and technical operations functions.
• Serve as technical subject matter expert (SME) for all medical device products.
• Collaborates with new product development teams to ensure successful integration of new products into manufacturing.
• Visits 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).
• 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 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.
• Develops standard operations 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 or errors/nonconformances and implement appropriate 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.
• Holds 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.
• Other duties as assigned.
• Collaborates with Audit & Risk Management function to identify business risks, and develop and implement preventive strategies for functional area